Trial Outcomes & Findings for A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women. (NCT NCT05045144)

Last Updated: 2023-10-05

Results Overview

Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1586 participants

Primary outcome timeframe

From Day 1 to Day 7 (including Day 7)

Results posted on

2023-10-05

Participant Flow

Out of 1586 participants enrolled,47 participants did not receive vaccination as they did not meet the eligibility criteria or they were lost to follow up, therefore only 1539 participants were included in the Exposed Set and started the study.

As pre-specified in statistical plan, data reported in Participant Flow, Baseline Characteristics and Adverse Events were presented for individual RSV lot groups, pooled RSV+Flu group (since minimal differences were expected between participants who received different RSV lots of the vaccine) and Flu+Placebo Group. As pre-specified in protocol, immunogenicity outcome measures presented data for the pooled RSV and RSV+Flu groups, and individual RSV lot groups were used for lot-to-lot analyses.

Participant milestones

Participant milestones
Measure	RSV lot1 Group Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV lot2 Group Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV lot3 Group Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV+Flu Pooled Group Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Overall Study STARTED	220	223	218	438	440
Overall Study COMPLETED	217	220	214	433	427
Overall Study NOT COMPLETED	3	3	4	5	13

Reasons for withdrawal

Reasons for withdrawal
Measure	RSV lot1 Group Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV lot2 Group Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV lot3 Group Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV+Flu Pooled Group Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Overall Study Lost to Follow-up	3	2	3	5	13
Overall Study Withdrawal by Subject	0	1	0	0	0
Overall Study MIGRATED / MOVED FROM THE STUDY AREA	0	0	1	0	0

Baseline Characteristics

A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RSV lot1 Group n=220 Participants Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV lot2 Group n=223 Participants Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV lot3 Group n=218 Participants Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV+Flu Pooled Group n=438 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=440 Participants Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.	Total n=1539 Participants Total of all reporting groups
Age, Continuous	32.0 YEARS STANDARD_DEVIATION 9.6 • n=5 Participants	31.4 YEARS STANDARD_DEVIATION 9.4 • n=7 Participants	31.9 YEARS STANDARD_DEVIATION 9.3 • n=5 Participants	32.0 YEARS STANDARD_DEVIATION 8.9 • n=4 Participants	32.1 YEARS STANDARD_DEVIATION 8.9 • n=21 Participants	31.9 YEARS STANDARD_DEVIATION 9.1 • n=8 Participants
Sex: Female, Male Female	220 Participants n=5 Participants	223 Participants n=7 Participants	218 Participants n=5 Participants	438 Participants n=4 Participants	440 Participants n=21 Participants	1539 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants	7 Participants n=21 Participants	26 Participants n=8 Participants
Race/Ethnicity, Customized ASIAN	22 Participants n=5 Participants	25 Participants n=7 Participants	21 Participants n=5 Participants	38 Participants n=4 Participants	43 Participants n=21 Participants	149 Participants n=8 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	12 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants	17 Participants n=21 Participants	55 Participants n=8 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized OTHER	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants	18 Participants n=8 Participants
Race/Ethnicity, Customized WHITE	183 Participants n=5 Participants	187 Participants n=7 Participants	185 Participants n=5 Participants	369 Participants n=4 Participants	366 Participants n=21 Participants	1290 Participants n=8 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 7 (including Day 7)

Population: Analysis was performed on the Solicited Safety Set (SSS), which includes all participants who received at least 1 dose of the study intervention (Exposed Set \[ES\]) and who have solicited safety data.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=660 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=438 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=439 Participants Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group Pain	53.6 Percentage of participants Interval 49.7 to 57.5	51.1 Percentage of participants Interval 46.4 to 55.9	34.4 Percentage of participants Interval 30.0 to 39.0
Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group Erythema	4.4 Percentage of participants Interval 3.0 to 6.2	3.7 Percentage of participants Interval 2.1 to 5.9	0.5 Percentage of participants Interval 0.1 to 1.6
Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group Swelling	4.5 Percentage of participants Interval 3.1 to 6.4	4.6 Percentage of participants Interval 2.8 to 7.0	0.9 Percentage of participants Interval 0.2 to 2.3

PRIMARY outcome

Timeframe: From Day 1 to Day 7 (including Day 7)

Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature was the oral cavity. Fever was defined as temperature equal to or above (≥) 38.0 °C/ 100.4°F. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=660 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=438 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=439 Participants Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group Vomiting	2.3 Percentage of participants Interval 1.3 to 3.7	1.8 Percentage of participants Interval 0.8 to 3.6	2.3 Percentage of participants Interval 1.1 to 4.1
Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group Diarrhea	12.1 Percentage of participants Interval 9.7 to 14.9	13 Percentage of participants Interval 10.0 to 16.5	17.1 Percentage of participants Interval 13.7 to 20.9
Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group Fatigue	52 Percentage of participants Interval 48.1 to 55.8	59.8 Percentage of participants Interval 55.1 to 64.4	51.9 Percentage of participants Interval 47.1 to 56.7
Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group Headache	47.6 Percentage of participants Interval 43.7 to 51.5	51.4 Percentage of participants Interval 46.6 to 56.1	43.1 Percentage of participants Interval 38.4 to 47.8
Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group Nausea	14.5 Percentage of participants Interval 11.9 to 17.5	15.3 Percentage of participants Interval 12.1 to 19.0	12.3 Percentage of participants Interval 9.4 to 15.7
Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group Abdominal pain	12 Percentage of participants Interval 9.6 to 14.7	13.5 Percentage of participants Interval 10.4 to 17.0	14.1 Percentage of participants Interval 11.0 to 17.7
Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group Temperature	2.4 Percentage of participants Interval 1.4 to 3.9	3 Percentage of participants Interval 1.6 to 5.0	0.7 Percentage of participants Interval 0.1 to 2.0

PRIMARY outcome

Timeframe: From Day 1 to Day 30 (including Day 30)

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

An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=661 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=438 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=440 Participants Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group	26.6 Percentage of participants Interval 23.3 to 30.2	30.1 Percentage of participants Interval 25.9 to 34.7	25.7 Percentage of participants Interval 21.7 to 30.0

PRIMARY outcome

Timeframe: From Day 1 to Day 30 (including Day 30)

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

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 or results i+F2n abnormal pregnancy outcomes. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=661 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=438 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=440 Participants Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group	0.2 Percentage of participants Interval 0.0 to 0.8	0 Percentage of participants Interval 0.0 to 0.8	0.2 Percentage of participants Interval 0.0 to 1.3

PRIMARY outcome

Timeframe: From first vaccination up to study end (Day 1 to Day 181)

Population: Analysis is performed on the ES, which includes all participants who received at least 1 dose of the study treatment.

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 or results in abnormal pregnancy outcomes.This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=661 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=438 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=440 Participants Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group	0.8 Percentage of participants Interval 0.2 to 1.8	0.9 Percentage of participants Interval 0.2 to 2.3	0.9 Percentage of participants Interval 0.2 to 2.3

PRIMARY outcome

Timeframe: At Day 31

Population: Analysis was performed on the Per Protocol Set (PPS), only on the participants who received only 1 dose of RSV MAT vaccine (from RSV MAT vaccine Lot 1, Lot 2 or Lot 3), and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.

Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EU/mL). As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze RSV MAT IgG ELISA concentrations, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=201 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=204 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=207 Participants Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
RSV MAT Immunoglobulin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 31	102811.0 EU/mL Interval 95243.6 to 110979.6	100635.8 EU/mL Interval 92970.2 to 108933.4	108709.3 EU/mL Interval 101913.7 to 115958.0

PRIMARY outcome

Timeframe: At Day 31

Population: Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of Flu D-QIV vaccine and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.

Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=398 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=404 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 A/Tasmania/503/2020 (H3N2)	301.6 Titers Interval 274.0 to 331.9	421.3 Titers Interval 383.4 to 463.0	—
Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 B/Washington/02/2019	30.7 Titers Interval 27.3 to 34.6	33.0 Titers Interval 29.3 to 37.2	—
Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 B/Phuket/3073/2013	56.2 Titers Interval 50.7 to 62.3	69.9 Titers Interval 62.6 to 77.9	—

SECONDARY outcome

Timeframe: At Day 1 and Day 31

Population: Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of RSV MAT vaccine (from one of the 3 lots used) and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.

Serological assays for the determilnation of antibodies against RSV A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as geometric mean titers (GMTs), in serum dilution inducing 60% inhibition in plaque forming units (ED60). This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV A neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=657 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=436 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 Day 1	721.6 Titers Interval 676.5 to 769.7	707.2 Titers Interval 653.4 to 765.5	—
RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 Day 31	8900.9 Titers Interval 8272.1 to 9577.5	7761.6 Titers Interval 7092.8 to 8493.6	—

SECONDARY outcome

Timeframe: At Day 31

The SCR was defined as the percentage of participants with: a Day 1 (pre-vaccination) serum anti-HI titer \<1:10 and a Day 31 (post-vaccination) serum anti-HI titer ≥1:40, or a Day 1 (pre-vaccination) serum anti-HI titer ≥ 1:10 and a fold increase (post/pre) ≥ 4 at Day 31. The 3 influenza strains assessed were: A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019 and B/Phuket/3073/2013. This objective analyzed the seroconversion rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=398 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=403 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Seroconversion Rate (SCR) to Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 A/Tasmania/503/2020 (H3N2)	42.5 Percentage of participants Interval 37.6 to 47.5	45.9 Percentage of participants Interval 41.0 to 50.9	—
Seroconversion Rate (SCR) to Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 B/Washington/02/2019	25.4 Percentage of participants Interval 21.2 to 30.0	29.5 Percentage of participants Interval 25.1 to 34.2	—
Seroconversion Rate (SCR) to Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31 B/Phuket/3073/2013	31.4 Percentage of participants Interval 26.9 to 36.2	35.5 Percentage of participants Interval 30.8 to 40.4	—

SECONDARY outcome

Timeframe: At Day 1 and Day 31

Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV B neutralizing antibody. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=656 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=436 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
RSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 Day 1	967.4 Titers Interval 909.5 to 1028.9	940.1 Titers Interval 871.0 to 1014.6	—
RSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 Day 31	11030.5 Titers Interval 10344.5 to 11762.0	9162.3 Titers Interval 8483.3 to 9895.8	—

SECONDARY outcome

Timeframe: At Day 1 and Day 31

Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV MAT IgG concentrations. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=657 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=436 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
RSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 Day 1	5522.7 EU/mL Interval 5285.7 to 5770.4	5772 EU/mL Interval 5455.8 to 6106.4	—
RSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31 Day 31	104025.1 EU/mL Interval 99714.5 to 108522.2	83937 EU/mL Interval 79640.9 to 88464.9	—

SECONDARY outcome

Timeframe: At Day 1 and Day 31

Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221;B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=436 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=437 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 A/Tasmania/503/2020 (H3N2) , Day 1	92.2 Titers Interval 81.2 to 104.8	110.3 Titers Interval 97.2 to 125.1	—
Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 A/Tasmania/503/2020 (H3N2) , Day 31	301.6 Titers Interval 274.0 to 331.9	421.3 Titers Interval 383.4 to 463.0	—
Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 B/Washington/02/2019 , Day 1	11.7 Titers Interval 10.6 to 13.0	10.3 Titers Interval 9.4 to 11.3	—
Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 B/Washington/02/2019 , Day 31	30.7 Titers Interval 27.3 to 34.6	33 Titers Interval 29.3 to 37.2	—
Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 B/Phuket/3073/2013 , Day 1	21.2 Titers Interval 19.0 to 23.7	21.9 Titers Interval 19.6 to 24.5	—
Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 B/Phuket/3073/2013 , Day 31	56.2 Titers Interval 50.7 to 62.3	69.9 Titers Interval 62.6 to 77.9	—

SECONDARY outcome

Timeframe: At Day 1 and Day 31

SPR was measured by the percentage of participants achieving an HI antibody titer ≥1:40. This objective analyzed the seroprotection rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=436 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=437 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 B/Phuket/3073/2013 , Day 1	36.7 Percentage of participants Interval 32.2 to 41.4	39.8 Percentage of participants Interval 35.2 to 44.6	—
Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 B/Phuket/3073/2013 , Day 31	74.4 Percentage of participants Interval 69.8 to 78.6	77.2 Percentage of participants Interval 72.8 to 81.2	—
Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 A/Tasmania/503/2020 (H3N2) , Day 1	78.7 Percentage of participants Interval 74.5 to 82.4	82.8 Percentage of participants Interval 79.0 to 86.3	—
Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 A/Tasmania/503/2020 (H3N2) , Day 31	98 Percentage of participants Interval 96.1 to 99.1	98.5 Percentage of participants Interval 96.8 to 99.5	—
Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 B/Washington/02/2019 , Day 1	19.7 Percentage of participants Interval 16.1 to 23.8	16.9 Percentage of participants Interval 13.5 to 20.8	—
Seroprotection Rate (SPR) to Flu D-QIV HI Antibody Titers for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31 B/Washington/02/2019 , Day 31	48 Percentage of participants Interval 43.0 to 53.0	48.8 Percentage of participants Interval 43.8 to 53.8	—

SECONDARY outcome

Timeframe: At Day 1 and Day 31

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV A neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=217 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=223 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=217 Participants Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
RSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 Day 31	8545.5 Titers Interval 7464.4 to 9783.2	8760.3 Titers Interval 7716.2 to 9945.8	9409.2 Titers Interval 8343.5 to 10611.0
RSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 Day 1	727.5 Titers Interval 652.0 to 811.6	758.4 Titers Interval 676.7 to 849.9	680.2 Titers Interval 607.4 to 761.7

SECONDARY outcome

Timeframe: At Day 1 and Day 31

Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the humoral immune response of RSV B neutralizing antibody titers, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=216 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=223 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=217 Participants Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
RSV B Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 Day 1	895 Titers Interval 810.6 to 988.2	1030.3 Titers Interval 929.3 to 1142.3	979.7 Titers Interval 870.6 to 1102.4
RSV B Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 Day 31	10457 Titers Interval 9258.5 to 11810.6	11107.2 Titers Interval 9984.4 to 12356.4	11543.3 Titers Interval 10377.6 to 12840.1

SECONDARY outcome

Timeframe: At Day 1 and Day 31

Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze the RSV MAT IgG concentration, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

Outcome measures

Outcome measures
Measure	RSV Pooled Group n=217 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) on Day 1, from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and were followed up until the end of the study (Day 181). On Day 31 (Visit 2), participants in this group had the option to receive the Flu D-QIV vaccine, as part of their standard of care. This group was considered for the immunogenicity and safety analysis of the RSV MAT vaccine.	RSV+Flu Pooled Group n=223 Participants Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=217 Participants Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
RSV MAT IgG Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 Day 1	5691.9 EU/mL Interval 5276.8 to 6139.7	5613 EU/mL Interval 5197.8 to 6061.3	5270.1 EU/mL Interval 4883.6 to 5687.1
RSV MAT IgG Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31 Day 31	102811 EU/mL Interval 95243.6 to 110979.6	100635.8 EU/mL Interval 92970.2 to 108933.4	108709.3 EU/mL Interval 101913.7 to 115958.0

Adverse Events

RSV lot1 Group

Serious events: 2 serious events

Other events: 182 other events

Deaths: 0 deaths

RSV lot2 Group

Serious events: 1 serious events

Other events: 193 other events

Deaths: 0 deaths

RSV lot3 Group

Serious events: 2 serious events

Other events: 194 other events

Deaths: 0 deaths

RSV+Flu Pooled Group

Serious events: 4 serious events

Other events: 409 other events

Deaths: 0 deaths

Flu+Placebo Group

Serious events: 4 serious events

Other events: 396 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RSV lot1 Group n=220 participants at risk Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV lot2 Group n=223 participants at risk Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV lot3 Group n=218 participants at risk Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV+Flu Pooled Group n=438 participants at risk Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=440 participants at risk Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Musculoskeletal and connective tissue disorders Joint ankylosis	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Greater trochanteric pain syndrome	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Overdose	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Psychiatric disorders Suicidal ideation	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Psychiatric disorders Suicide attempt	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Appendicitis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations COVID-19 pneumonia	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Eye disorders Optic neuropathy	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Hepatobiliary disorders Cholelithiasis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.

Other adverse events

Other adverse events
Measure	RSV lot1 Group n=220 participants at risk Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV lot2 Group n=223 participants at risk Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV lot3 Group n=218 participants at risk Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.	RSV+Flu Pooled Group n=438 participants at risk Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.	Flu+Placebo Group n=440 participants at risk Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
General disorders Administration site pain	49.1% 108/220 • Number of events 108 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	58.7% 131/223 • Number of events 131 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	52.8% 115/218 • Number of events 115 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	82.2% 360/438 • Number of events 440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	74.3% 327/440 • Number of events 346 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Fatigue	50.0% 110/220 • Number of events 112 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	50.7% 113/223 • Number of events 113 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	55.5% 121/218 • Number of events 123 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	60.0% 263/438 • Number of events 268 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	52.3% 230/440 • Number of events 233 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Administration site swelling	4.1% 9/220 • Number of events 9 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	4.9% 11/223 • Number of events 11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	4.6% 10/218 • Number of events 10 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	7.3% 32/438 • Number of events 35 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	3.2% 14/440 • Number of events 14 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Administration site erythema	4.5% 10/220 • Number of events 10 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	4.0% 9/223 • Number of events 9 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	4.6% 10/218 • Number of events 10 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	4.1% 18/438 • Number of events 19 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.6% 7/440 • Number of events 7 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Pyrexia	2.7% 6/220 • Number of events 6 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.3% 3/223 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	3.7% 8/218 • Number of events 8 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	3.2% 14/438 • Number of events 14 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Axillary pain	1.8% 4/220 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	2.2% 5/223 • Number of events 5 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.8% 4/218 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.4% 6/438 • Number of events 6 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Swelling	2.3% 5/220 • Number of events 5 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/438 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Injection site pain	1.8% 4/220 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.1% 5/440 • Number of events 5 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Injection site lymphadenopathy	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.3% 3/223 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.92% 2/218 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Discomfort	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.92% 2/218 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.91% 4/438 • Number of events 5 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Pain	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 2/438 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Chills	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.4% 6/438 • Number of events 6 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Malaise	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/438 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Injection site pruritus	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 2/438 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Injection site haematoma	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Injection site swelling	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Asthenia	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Influenza like illness	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Administration site warmth	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Injection site discomfort	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Injection site extravasation	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Vaccination site haematoma	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Vaccination site rash	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Chest discomfort	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Chest pain	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Feeling hot	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Injection site erythema	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Temperature regulation disorder	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
General disorders Vaccination site pain	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Nervous system disorders Headache	50.0% 110/220 • Number of events 122 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	48.4% 108/223 • Number of events 115 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	49.5% 108/218 • Number of events 111 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	51.8% 227/438 • Number of events 247 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	44.5% 196/440 • Number of events 209 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Nervous system disorders Migraine	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 2/438 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Nervous system disorders Dizziness	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 2/438 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Nervous system disorders Hypoaesthesia	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Nervous system disorders Paraesthesia	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Nervous system disorders Idiopathic intracranial hypertension	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Nervous system disorders Syncope	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Nervous system disorders Dizziness exertional	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Nausea	15.5% 34/220 • Number of events 35 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	13.9% 31/223 • Number of events 32 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	14.7% 32/218 • Number of events 33 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	15.5% 68/438 • Number of events 72 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	12.3% 54/440 • Number of events 56 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Diarrhoea	13.2% 29/220 • Number of events 29 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	11.2% 25/223 • Number of events 27 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	12.8% 28/218 • Number of events 28 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	13.5% 59/438 • Number of events 64 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	17.5% 77/440 • Number of events 77 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Abdominal pain	11.4% 25/220 • Number of events 25 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	14.8% 33/223 • Number of events 33 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	11.5% 25/218 • Number of events 25 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	13.9% 61/438 • Number of events 61 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	14.3% 63/440 • Number of events 64 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Vomiting	3.2% 7/220 • Number of events 7 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	2.2% 5/223 • Number of events 5 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.4% 3/218 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	2.1% 9/438 • Number of events 9 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	2.5% 11/440 • Number of events 11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Flatulence	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Gastritis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Constipation	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Dyspepsia	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Odynophagia	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Gastrointestinal disorders Volvulus	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Nasopharyngitis	1.8% 4/220 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.8% 4/223 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.92% 2/218 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	3.0% 13/438 • Number of events 13 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	3.4% 15/440 • Number of events 15 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Upper respiratory tract infection	1.8% 4/220 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.4% 3/218 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.8% 8/438 • Number of events 8 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations COVID-19	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.8% 4/218 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.6% 7/438 • Number of events 7 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Urinary tract infection	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.92% 2/218 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/438 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Sinusitis	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.92% 2/218 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Influenza	1.4% 3/220 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 2/438 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Bronchitis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.4% 3/218 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Pharyngotonsillitis	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Gastroenteritis viral	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Respiratory tract infection	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Tonsillitis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Nasal herpes	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Cystitis	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Eczema impetiginous	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Laryngitis	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Upper respiratory tract infection bacterial	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Vulvovaginitis	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Ear infection	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Oral herpes	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Pharyngitis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Pharyngitis streptococcal	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 2/438 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Conjunctivitis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Gastroenteritis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Bacterial vulvovaginitis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Fungal infection	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Gingivitis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Otitis media acute	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Respiratory tract infection bacterial	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Suspected COVID-19	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Bacterial vaginosis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Otitis externa	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Pneumonia	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Respiratory tract infection viral	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Streptococcal infection	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Infections and infestations Viral infection	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.4% 3/220 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.3% 3/223 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	2.3% 5/218 • Number of events 5 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.4% 6/438 • Number of events 6 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.4% 6/440 • Number of events 6 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Cough	0.91% 2/220 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.8% 8/438 • Number of events 8 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.4% 6/440 • Number of events 6 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.8% 4/218 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/438 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.1% 5/440 • Number of events 5 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.3% 3/223 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.92% 2/218 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.4% 6/438 • Number of events 6 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.91% 4/440 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Aphonia	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Respiratory, thoracic and mediastinal disorders Pulmonary calcification	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Myalgia	0.91% 2/220 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.8% 4/223 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.91% 4/438 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.1% 5/440 • Number of events 5 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 3/220 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/438 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Pain in extremity	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.91% 4/438 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Neck pain	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 2/438 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/438 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Axillary mass	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Blood and lymphatic system disorders Lymphadenopathy	2.7% 6/220 • Number of events 6 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	3.1% 7/223 • Number of events 8 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	2.3% 5/218 • Number of events 5 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	1.4% 6/438 • Number of events 6 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.91% 4/440 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.68% 3/438 • Number of events 3 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Skin and subcutaneous tissue disorders Rash	0.91% 2/220 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Ear and labyrinth disorders Vertigo	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 2/438 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Ear and labyrinth disorders External ear inflammation	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Ear and labyrinth disorders Vertigo positional	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Ear and labyrinth disorders Excessive cerumen production	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Ear and labyrinth disorders Ear pain	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Ear and labyrinth disorders Eustachian tube disorder	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Limb injury	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.90% 2/223 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Fall	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Lip injury	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Concussion	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Animal bite	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Fascial rupture	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 2/440 • Number of events 2 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Reproductive system and breast disorders Menstrual disorder	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.46% 1/218 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Reproductive system and breast disorders Menopausal symptoms	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 4 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Eye disorders Eye symptom	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Eye disorders Eczema eyelids	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Eye disorders Blepharitis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Eye disorders Vision blurred	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Renal and urinary disorders Bladder pain	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Renal and urinary disorders Dysuria	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Investigations Body temperature increased	0.45% 1/220 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Investigations Blood pressure decreased	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Investigations Smear cervix abnormal	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Vascular disorders Hot flush	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Vascular disorders Hypertension	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Psychiatric disorders Insomnia	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Psychiatric disorders Bipolar disorder	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Psychiatric disorders Irritability	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Social circumstances High risk sexual behaviour	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.45% 1/223 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Immune system disorders Food allergy	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Immune system disorders Immunisation reaction	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/438 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/440 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Congenital, familial and genetic disorders Supernumerary teeth	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/220 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/223 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/218 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.23% 1/438 • Number of events 1 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.	0.00% 0/440 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included. As pre-specified in protocol, adverse events were presented for individual RSV lot groups, RSV+Flu pooled Group (since minimal differences were expected in adverse events between participants who received different lots of the vaccine) and Flu+Placebo group. Participants that received the Flu vaccine only as standard of care (group RSV pooled) were not included for safety analyses after receiving the Flu vaccine, as this was not a study objective.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

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