Trial Outcomes & Findings for A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women (NCT NCT04138056)

Last Updated: 2024-08-21

Results Overview

Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA). The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

509 participants

Primary outcome timeframe

At Day 8

Results posted on

2024-08-21

Participant Flow

Data reported in the participant flow, baseline characteristics and the immunogenicity outcome measures of the Extension Study were only analyzed for pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled)\], as the two formulations of dTpa vaccine (containing 300 micrograms(μg) or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.

Participant milestones

Participant milestones
Measure	RSV120_dTpa_RSV120(Pooled) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(Pooled) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(Pooled) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(Pooled) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(Pooled) Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Primary Study STARTED	101	101	103	102	102
Primary Study COMPLETED	95	93	100	100	98
Primary Study NOT COMPLETED	6	8	3	2	4
Extension Study STARTED	39	41	46	41	46
Extension Study COMPLETED	38	39	45	41	45
Extension Study NOT COMPLETED	1	2	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	RSV120_dTpa_RSV120(Pooled) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(Pooled) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(Pooled) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(Pooled) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(Pooled) Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Primary Study Lost to Follow-up	3	4	1	1	4
Primary Study ELIGIBILITY CRITERIA NOT FULFILLED (INCLUSION AND EXCLUSION CRITERIA)	3	4	2	1	0
Extension Study Lost to Follow-up	1	2	1	0	1

Baseline Characteristics

Age, Extension Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RSV120_dTpa_RSV120(Pooled) n=101 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(Pooled) n=101 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(Pooled) n=103 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(Pooled) n=102 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(Pooled) n=102 Participants Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	Total n=509 Participants Total of all reporting groups
Age, Customized	32.1 Years STANDARD_DEVIATION 7.9 • n=39 Participants • Age, Extension Study	31.7 Years STANDARD_DEVIATION 8.4 • n=41 Participants • Age, Extension Study	30.4 Years STANDARD_DEVIATION 8.6 • n=46 Participants • Age, Extension Study	30.3 Years STANDARD_DEVIATION 8.4 • n=41 Participants • Age, Extension Study	32.6 Years STANDARD_DEVIATION 8.2 • n=46 Participants • Age, Extension Study	31.4 Years STANDARD_DEVIATION 8.3 • n=213 Participants • Age, Extension Study
Sex/Gender, Customized Female	39 Participants n=39 Participants • Sex/Gender, Extension Study	41 Participants n=41 Participants • Sex/Gender, Extension Study	46 Participants n=46 Participants • Sex/Gender, Extension Study	41 Participants n=41 Participants • Sex/Gender, Extension Study	46 Participants n=46 Participants • Sex/Gender, Extension Study	213 Participants n=213 Participants • Sex/Gender, Extension Study
Sex/Gender, Customized Male	0 Participants n=39 Participants • Sex/Gender, Extension Study	0 Participants n=41 Participants • Sex/Gender, Extension Study	0 Participants n=46 Participants • Sex/Gender, Extension Study	0 Participants n=41 Participants • Sex/Gender, Extension Study	0 Participants n=46 Participants • Sex/Gender, Extension Study	0 Participants n=213 Participants • Sex/Gender, Extension Study
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	1 Participants n=39 Participants • Race/Ethnicity, Extension Study	0 Participants n=41 Participants • Race/Ethnicity, Extension Study	0 Participants n=46 Participants • Race/Ethnicity, Extension Study	0 Participants n=41 Participants • Race/Ethnicity, Extension Study	0 Participants n=46 Participants • Race/Ethnicity, Extension Study	1 Participants n=213 Participants • Race/Ethnicity, Extension Study
Race/Ethnicity, Customized ASIAN	1 Participants n=39 Participants • Race/Ethnicity, Extension Study	0 Participants n=41 Participants • Race/Ethnicity, Extension Study	1 Participants n=46 Participants • Race/Ethnicity, Extension Study	2 Participants n=41 Participants • Race/Ethnicity, Extension Study	0 Participants n=46 Participants • Race/Ethnicity, Extension Study	4 Participants n=213 Participants • Race/Ethnicity, Extension Study
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	0 Participants n=39 Participants • Race/Ethnicity, Extension Study	0 Participants n=41 Participants • Race/Ethnicity, Extension Study	1 Participants n=46 Participants • Race/Ethnicity, Extension Study	0 Participants n=41 Participants • Race/Ethnicity, Extension Study	1 Participants n=46 Participants • Race/Ethnicity, Extension Study	2 Participants n=213 Participants • Race/Ethnicity, Extension Study
Race/Ethnicity, Customized OTHER Not specified	1 Participants n=39 Participants • Race/Ethnicity, Extension Study	0 Participants n=41 Participants • Race/Ethnicity, Extension Study	2 Participants n=46 Participants • Race/Ethnicity, Extension Study	0 Participants n=41 Participants • Race/Ethnicity, Extension Study	1 Participants n=46 Participants • Race/Ethnicity, Extension Study	4 Participants n=213 Participants • Race/Ethnicity, Extension Study
Race/Ethnicity, Customized WHITE	36 Participants n=39 Participants • Race/Ethnicity, Extension Study	41 Participants n=41 Participants • Race/Ethnicity, Extension Study	42 Participants n=46 Participants • Race/Ethnicity, Extension Study	39 Participants n=41 Participants • Race/Ethnicity, Extension Study	44 Participants n=46 Participants • Race/Ethnicity, Extension Study	202 Participants n=213 Participants • Race/Ethnicity, Extension Study

PRIMARY outcome

Timeframe: From Day 1 to Day 8

Population: The analysis was performed on the Solicited Safety Set (SSS) - Primary Study which consisted of all subjects from the Exposed set (ES) - Primary Study for whom solicited safety data were available.

Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=101 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=99 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=100 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=103 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] RSVPreF3 (Left Arm), Swelling	—	2 Percentage of participants Interval 0.2 to 7.0	4.9 Percentage of participants Interval 1.6 to 11.1	0 Percentage of participants Interval 0.0 to 3.7	7 Percentage of participants Interval 2.9 to 13.9	2.9 Percentage of participants Interval 0.6 to 8.3	—	—	—	—
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] RSVPreF3 (Left Arm), Erythema	—	5.9 Percentage of participants Interval 2.2 to 12.5	5.9 Percentage of participants Interval 2.2 to 12.4	0 Percentage of participants Interval 0.0 to 3.7	5 Percentage of participants Interval 1.6 to 11.3	5.8 Percentage of participants Interval 2.2 to 12.2	—	—	—	—
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] RSVPreF3 (Left Arm), Pain	—	51.5 Percentage of participants Interval 41.3 to 61.6	58.8 Percentage of participants Interval 48.6 to 68.5	19.2 Percentage of participants Interval 12.0 to 28.3	54 Percentage of participants Interval 43.7 to 64.0	52.4 Percentage of participants Interval 42.4 to 62.4	—	—	—	—
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] dTpa (Right Arm), Erythema	—	4 Percentage of participants Interval 1.1 to 9.8	1 Percentage of participants Interval 0.0 to 5.3	6.1 Percentage of participants Interval 2.3 to 12.7	1 Percentage of participants Interval 0.0 to 5.4	4.9 Percentage of participants Interval 1.6 to 11.0	—	—	—	—
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] dTpa (Right Arm), Pain	—	81.2 Percentage of participants Interval 72.2 to 88.3	18.6 Percentage of participants Interval 11.6 to 27.6	78.8 Percentage of participants Interval 69.4 to 86.4	25 Percentage of participants Interval 16.9 to 34.7	76.7 Percentage of participants Interval 67.3 to 84.5	—	—	—	—
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study] dTpa (Right Arm), Swelling	—	5 Percentage of participants Interval 1.6 to 11.2	1 Percentage of participants Interval 0.0 to 5.3	4 Percentage of participants Interval 1.1 to 10.0	0 Percentage of participants Interval 0.0 to 3.6	1.9 Percentage of participants Interval 0.2 to 6.8	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 to Day 8

Population: The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.

Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever (body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=101 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=99 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=101 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=103 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Percentage of Subjects With Any Solicited General AEs [Primary Study] Fatigue	—	40.6 Percentage of participants Interval 30.9 to 50.8	32.4 Percentage of participants Interval 23.4 to 42.3	38.4 Percentage of participants Interval 28.8 to 48.7	39.6 Percentage of participants Interval 30.0 to 49.8	37.9 Percentage of participants Interval 28.5 to 48.0	—	—	—	—
Percentage of Subjects With Any Solicited General AEs [Primary Study] Gastrointestinal symptoms	—	23.8 Percentage of participants Interval 15.9 to 33.3	28.4 Percentage of participants Interval 19.9 to 38.2	28.3 Percentage of participants Interval 19.7 to 38.2	28.7 Percentage of participants Interval 20.1 to 38.6	27.2 Percentage of participants Interval 18.9 to 36.8	—	—	—	—
Percentage of Subjects With Any Solicited General AEs [Primary Study] Headache	—	44.6 Percentage of participants Interval 34.7 to 54.8	39.2 Percentage of participants Interval 29.7 to 49.4	37.4 Percentage of participants Interval 27.9 to 47.7	45.5 Percentage of participants Interval 35.6 to 55.8	35 Percentage of participants Interval 25.8 to 45.0	—	—	—	—
Percentage of Subjects With Any Solicited General AEs [Primary Study] Temperature	—	2 Percentage of participants Interval 0.2 to 7.0	3.9 Percentage of participants Interval 1.1 to 9.7	7.1 Percentage of participants Interval 2.9 to 14.0	4 Percentage of participants Interval 1.1 to 9.8	2.9 Percentage of participants Interval 0.6 to 8.3	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 to Day 31

Population: The analysis was performed on the ES - Primary Study which consisted of all subjects 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 to be reported as an unsolicited AE. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=101 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=101 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=103 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Percentage of Subjects With Any Unsolicited AEs [Primary Study]	—	38.6 Percentage of participants Interval 29.1 to 48.8	37.3 Percentage of participants Interval 27.9 to 47.4	32.4 Percentage of participants Interval 23.4 to 42.3	34.7 Percentage of participants Interval 25.5 to 44.8	33 Percentage of participants Interval 24.1 to 43.0	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 to Day 31

Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=101 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=101 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=103 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Number of Subjects With Any SAEs [Primary Study]	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: From the Day of 2nd vaccination to Day 8 post 2nd vaccination

Population: The analysis was performed on the SSS - Extension Study which consisted of all subjects from the ES - Extension Study for whom solicited safety data were available.

Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=39 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=41 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=44 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=39 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=46 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Percentage of Subjects With Any Solicited Local AEs [Extension Study] Erythema	—	17.9 Percentage of participants Interval 7.5 to 33.5	14.6 Percentage of participants Interval 5.6 to 29.2	2.3 Percentage of participants Interval 0.1 to 12.0	10.3 Percentage of participants Interval 2.9 to 24.2	8.7 Percentage of participants Interval 2.4 to 20.8	—	—	—	—
Percentage of Subjects With Any Solicited Local AEs [Extension Study] Pain	—	87.2 Percentage of participants Interval 72.6 to 95.7	85.4 Percentage of participants Interval 70.8 to 94.4	38.6 Percentage of participants Interval 24.4 to 54.5	87.2 Percentage of participants Interval 72.6 to 95.7	80.4 Percentage of participants Interval 66.1 to 90.6	—	—	—	—
Percentage of Subjects With Any Solicited Local AEs [Extension Study] Swelling	—	12.8 Percentage of participants Interval 4.3 to 27.4	4.9 Percentage of participants Interval 0.6 to 16.5	2.3 Percentage of participants Interval 0.1 to 12.0	7.7 Percentage of participants Interval 1.6 to 20.9	8.7 Percentage of participants Interval 2.4 to 20.8	—	—	—	—

PRIMARY outcome

Timeframe: From the Day of 2nd vaccination to Day 8 post 2nd vaccination

Population: The analysis was performed on the SSS - Extension Study which consisted of all subjects from the ES - Extension Study for whom solicited safety data were available.

Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=39 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=41 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=44 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=39 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=46 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Percentage of Subjects Any Solicited General AEs [Extension Period] Fatigue	—	25.6 Percentage of participants Interval 13.0 to 42.1	46.3 Percentage of participants Interval 30.7 to 62.6	34.1 Percentage of participants Interval 20.5 to 49.9	33.3 Percentage of participants Interval 19.1 to 50.2	37 Percentage of participants Interval 23.2 to 52.5	—	—	—	—
Percentage of Subjects Any Solicited General AEs [Extension Period] Gastrointestinal symptoms	—	10.3 Percentage of participants Interval 2.9 to 24.2	24.4 Percentage of participants Interval 12.4 to 40.3	13.6 Percentage of participants Interval 5.2 to 27.4	20.5 Percentage of participants Interval 9.3 to 36.5	15.2 Percentage of participants Interval 6.3 to 28.9	—	—	—	—
Percentage of Subjects Any Solicited General AEs [Extension Period] Headache	—	28.2 Percentage of participants Interval 15.0 to 44.9	56.1 Percentage of participants Interval 39.7 to 71.5	31.8 Percentage of participants Interval 18.6 to 47.6	33.3 Percentage of participants Interval 19.1 to 50.2	32.6 Percentage of participants Interval 19.5 to 48.0	—	—	—	—
Percentage of Subjects Any Solicited General AEs [Extension Period] Temperature	—	0 Percentage of participants Interval 0.0 to 9.0	9.8 Percentage of participants Interval 2.7 to 23.1	2.3 Percentage of participants Interval 0.1 to 12.0	0 Percentage of participants Interval 0.0 to 9.0	2.2 Percentage of participants Interval 0.1 to 11.5	—	—	—	—

PRIMARY outcome

Timeframe: From the Day of 2nd vaccination to Day 31 post 2nd vaccination

Population: The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=39 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=41 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=46 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=41 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=46 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Percentage of Subjects With Any Unsolicited AEs [Extension Period]	—	18 Percentage of participants Interval 8.0 to 34.0	29 Percentage of participants Interval 16.0 to 46.0	20 Percentage of participants Interval 9.0 to 34.0	20 Percentage of participants Interval 9.0 to 35.0	20 Percentage of participants Interval 9.0 to 34.0	—	—	—	—

PRIMARY outcome

Timeframe: From the Day of 2nd vaccination to Day 31 post 2nd vaccination

Population: The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=39 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=41 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=46 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=41 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=46 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Number of Subjects With Any SAEs [Extension Period]	—	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: At Screening (Day -7 to Day 1)

Population: The analysis was performed on the Per Protocol Set (PPS) - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60 (Estimated Dilution 60). The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=100 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=100 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=103 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study]	—	875 Titers (ED60) Interval 745.0 to 1027.0	771 Titers (ED60) Interval 673.0 to 883.0	1050 Titers (ED60) Interval 896.0 to 1231.0	1022 Titers (ED60) Interval 856.0 to 1222.0	1135 Titers (ED60) Interval 959.0 to 1342.0	—	—	—	—

PRIMARY outcome

Timeframe: At Day 8

Population: The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=98 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=100 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=99 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=100 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study]	—	14166 Titers (ED60) Interval 12213.0 to 16431.0	10590 Titers (ED60) Interval 8994.0 to 12469.0	783 Titers (ED60) Interval 661.0 to 929.0	14285 Titers (ED60) Interval 11999.0 to 17008.0	10185 Titers (ED60) Interval 8514.0 to 12183.0	—	—	—	—

PRIMARY outcome

Timeframe: At Day 31

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=98 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=99 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=97 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=97 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=102 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study]	—	9836 Titers (ED60) Interval 8252.0 to 11725.0	8739 Titers (ED60) Interval 7561.0 to 10101.0	845 Titers (ED60) Interval 705.0 to 1013.0	11038 Titers (ED60) Interval 9160.0 to 13301.0	9214 Titers (ED60) Interval 7806.0 to 10876.0	—	—	—	—

PRIMARY outcome

Timeframe: At Screening (Day -7 to Day 1)

Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA ). The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=100 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=100 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=103 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study]	—	6611 ELISA Units per milliliter (EU/mL) Interval 5857.0 to 7461.0	6172 ELISA Units per milliliter (EU/mL) Interval 5570.0 to 6840.0	6454 ELISA Units per milliliter (EU/mL) Interval 5771.0 to 7217.0	6751 ELISA Units per milliliter (EU/mL) Interval 5982.0 to 7620.0	7449 ELISA Units per milliliter (EU/mL) Interval 6534.0 to 8492.0	—	—	—	—

PRIMARY outcome

Timeframe: At Day 8

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=99 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=100 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=99 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=100 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV PreF3 IgG GMCs at Day 8 [Primary Study]	—	156568 EU/mL Interval 137244.0 to 178613.0	118670 EU/mL Interval 106004.0 to 132850.0	5780 EU/mL Interval 5145.0 to 6494.0	146708 EU/mL Interval 128639.0 to 167315.0	101662 EU/mL Interval 89783.0 to 115113.0	—	—	—	—

PRIMARY outcome

Timeframe: At Day 31

Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA). Analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=98 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=99 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=97 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=97 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=102 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV PreF3 IgG GMCs at Day 31 [Primary Study]	—	101813 EU/mL Interval 89290.0 to 116092.0	88938 EU/mL Interval 79738.0 to 99200.0	6149 EU/mL Interval 5474.0 to 6908.0	106082 EU/mL Interval 93597.0 to 120231.0	86273 EU/mL Interval 77415.0 to 96145.0	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 to Day 8

Population: The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=50 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=52 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=50 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] Right Arm, Erythema	3.9 Percentage of participants Interval 0.5 to 13.5	4 Percentage of participants Interval 0.5 to 13.7	2 Percentage of participants Interval 0.0 to 10.4	6.1 Percentage of participants Interval 1.3 to 16.9	2 Percentage of participants Interval 0.1 to 10.9	2 Percentage of participants Interval 0.0 to 10.4	0 Percentage of participants Interval 0.0 to 7.0	7.7 Percentage of participants Interval 2.1 to 18.5	0 Percentage of participants Interval 0.0 to 7.0	6 Percentage of participants Interval 1.3 to 16.5
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] Right Arm, Pain	76.5 Percentage of participants Interval 62.5 to 87.2	86 Percentage of participants Interval 73.3 to 94.2	23.5 Percentage of participants Interval 12.8 to 37.5	79.6 Percentage of participants Interval 65.7 to 89.8	18.4 Percentage of participants Interval 8.8 to 32.0	88.2 Percentage of participants Interval 76.1 to 95.6	31.4 Percentage of participants Interval 19.1 to 45.9	65.4 Percentage of participants Interval 50.9 to 78.0	13.7 Percentage of participants Interval 5.7 to 26.3	78 Percentage of participants Interval 64.0 to 88.5
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] Right Arm, Swelling	3.9 Percentage of participants Interval 0.5 to 13.5	6 Percentage of participants Interval 1.3 to 16.5	2 Percentage of participants Interval 0.0 to 10.4	6.1 Percentage of participants Interval 1.3 to 16.9	0 Percentage of participants Interval 0.0 to 7.3	3.9 Percentage of participants Interval 0.5 to 13.5	0 Percentage of participants Interval 0.0 to 7.0	0 Percentage of participants Interval 0.0 to 6.8	0 Percentage of participants Interval 0.0 to 7.0	2 Percentage of participants Interval 0.1 to 10.6
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] Left Arm, Erythema	5.9 Percentage of participants Interval 1.2 to 16.2	6 Percentage of participants Interval 1.3 to 16.5	2 Percentage of participants Interval 0.0 to 10.4	0 Percentage of participants Interval 0.0 to 7.3	4.1 Percentage of participants Interval 0.5 to 14.0	5.9 Percentage of participants Interval 1.2 to 16.2	5.9 Percentage of participants Interval 1.2 to 16.2	5.8 Percentage of participants Interval 1.2 to 15.9	9.8 Percentage of participants Interval 3.3 to 21.4	0 Percentage of participants Interval 0.0 to 7.1
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] Left Arm, Pain	56.9 Percentage of participants Interval 42.2 to 70.7	46 Percentage of participants Interval 31.8 to 60.7	60.8 Percentage of participants Interval 46.1 to 74.2	16.3 Percentage of participants Interval 7.3 to 29.7	53.1 Percentage of participants Interval 38.3 to 67.5	52.9 Percentage of participants Interval 38.5 to 67.1	54.9 Percentage of participants Interval 40.3 to 68.9	51.9 Percentage of participants Interval 37.6 to 66.0	56.9 Percentage of participants Interval 42.2 to 70.7	22 Percentage of participants Interval 11.5 to 36.0
Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study] Left Arm, Swelling	2 Percentage of participants Interval 0.0 to 10.4	2 Percentage of participants Interval 0.1 to 10.6	2 Percentage of participants Interval 0.0 to 10.4	0 Percentage of participants Interval 0.0 to 7.3	6.1 Percentage of participants Interval 1.3 to 16.9	3.9 Percentage of participants Interval 0.5 to 13.5	7.8 Percentage of participants Interval 2.2 to 18.9	1.9 Percentage of participants Interval 0.0 to 10.3	7.8 Percentage of participants Interval 2.2 to 18.9	0 Percentage of participants Interval 0.0 to 7.1

SECONDARY outcome

Timeframe: From Day 1 to Day 8

Population: The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.

Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=50 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=52 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=52 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=50 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] Fatigue	45.1 Percentage of participants Interval 31.1 to 59.7	36 Percentage of participants Interval 22.9 to 50.8	29.4 Percentage of participants Interval 17.5 to 43.8	34.7 Percentage of participants Interval 21.7 to 49.6	36.7 Percentage of participants Interval 23.4 to 51.7	39.2 Percentage of participants Interval 25.8 to 53.9	42.3 Percentage of participants Interval 28.7 to 56.8	36.5 Percentage of participants Interval 23.6 to 51.0	35.3 Percentage of participants Interval 22.4 to 49.9	42 Percentage of participants Interval 28.2 to 56.8
Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] Gastrointestinal symptoms	25.5 Percentage of participants Interval 14.3 to 39.6	22 Percentage of participants Interval 11.5 to 36.0	29.4 Percentage of participants Interval 17.5 to 43.8	30.6 Percentage of participants Interval 18.3 to 45.4	28.6 Percentage of participants Interval 16.6 to 43.3	23.5 Percentage of participants Interval 12.8 to 37.5	28.8 Percentage of participants Interval 17.1 to 43.1	30.8 Percentage of participants Interval 18.7 to 45.1	27.5 Percentage of participants Interval 15.9 to 41.7	26 Percentage of participants Interval 14.6 to 40.3
Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] Headache	43.1 Percentage of participants Interval 29.3 to 57.8	46 Percentage of participants Interval 31.8 to 60.7	45.1 Percentage of participants Interval 31.1 to 59.7	40.8 Percentage of participants Interval 27.0 to 55.8	38.8 Percentage of participants Interval 25.2 to 53.8	31.4 Percentage of participants Interval 19.1 to 45.9	51.9 Percentage of participants Interval 37.6 to 66.0	38.5 Percentage of participants Interval 25.3 to 53.0	33.3 Percentage of participants Interval 20.8 to 47.9	34 Percentage of participants Interval 21.2 to 48.8
Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study] Temperature	0 Percentage of participants Interval 0.0 to 7.0	4 Percentage of participants Interval 0.5 to 13.7	5.9 Percentage of participants Interval 1.2 to 16.2	12.2 Percentage of participants Interval 4.6 to 24.8	6.1 Percentage of participants Interval 1.3 to 16.9	3.9 Percentage of participants Interval 0.5 to 13.5	1.9 Percentage of participants Interval 0.0 to 10.3	1.9 Percentage of participants Interval 0.0 to 10.3	2 Percentage of participants Interval 0.0 to 10.4	2 Percentage of participants Interval 0.1 to 10.6

SECONDARY outcome

Timeframe: From Day 1 to Day 31

Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=50 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=52 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=52 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study]	39.2 Percentage of participants Interval 25.8 to 53.9	38 Percentage of participants Interval 24.7 to 52.8	43.1 Percentage of participants Interval 29.3 to 57.8	33.3 Percentage of participants Interval 20.8 to 47.9	36.7 Percentage of participants Interval 23.4 to 51.7	39.2 Percentage of participants Interval 25.8 to 53.9	32.7 Percentage of participants Interval 20.3 to 47.1	26.9 Percentage of participants Interval 15.6 to 41.0	31.4 Percentage of participants Interval 19.1 to 45.9	31.4 Percentage of participants Interval 19.1 to 45.9

SECONDARY outcome

Timeframe: From Day 1 to Day 31

Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=50 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=52 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=52 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study]	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 181

Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=101 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=102 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=101 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=103 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study]	—	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From Day 1 to Day 181

Population: The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=50 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=52 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=52 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Number of Subjects With Any SAEs From 1st Vaccination to Day 181 by Each Boostrix Formulation [Primary Study]	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the Day of 2nd vaccination to Day 181 post 2nd vaccination

Population: The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=39 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=41 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=46 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=41 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=46 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Number of Subjects With Any SAEs From 2nd Vaccination to Day 181 Post 2nd Vaccination [Extension Period]	—	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At Screening (Day -7 to Day 1)

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=52 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV A Neutralizing GMTs at Screening by Each Boostrix Formulation [Primary Study]	981 Titers (ED60) Interval 773.0 to 1245.0	777 Titers (ED60) Interval 625.0 to 966.0	777 Titers (ED60) Interval 631.0 to 956.0	956 Titers (ED60) Interval 740.0 to 1236.0	1009 Titers (ED60) Interval 798.0 to 1277.0	989 Titers (ED60) Interval 749.0 to 1307.0	1035 Titers (ED60) Interval 786.0 to 1362.0	1298 Titers (ED60) Interval 1070.0 to 1574.0	765 Titers (ED60) Interval 638.0 to 917.0	1154 Titers (ED60) Interval 952.0 to 1399.0

SECONDARY outcome

Timeframe: At Day 8

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=49 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=48 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=50 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=50 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=49 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV A Neutralizing GMTs at Day 8 by Each Boostrix Formulation [Primary Study]	13818 Titers (ED60) Interval 11070.0 to 17248.0	14523 Titers (ED60) Interval 11831.0 to 17827.0	11128 Titers (ED60) Interval 8885.0 to 13939.0	698 Titers (ED60) Interval 530.0 to 918.0	15458 Titers (ED60) Interval 12424.0 to 19231.0	10677 Titers (ED60) Interval 8146.0 to 13993.0	13264 Titers (ED60) Interval 10075.0 to 17462.0	9715 Titers (ED60) Interval 7612.0 to 12400.0	10077 Titers (ED60) Interval 7897.0 to 12858.0	884 Titers (ED60) Interval 722.0 to 1082.0

SECONDARY outcome

Timeframe: At Day 31

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=49 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=50 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=48 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=48 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=49 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV A Neutralizing GMTs at Day 31 by Each Boostrix Formulation [Primary Study]	9834 Titers (ED60) Interval 7354.0 to 13152.0	9838 Titers (ED60) Interval 7987.0 to 12118.0	8141 Titers (ED60) Interval 6545.0 to 10125.0	767 Titers (ED60) Interval 575.0 to 1023.0	10800 Titers (ED60) Interval 8675.0 to 13446.0	8754 Titers (ED60) Interval 6821.0 to 11236.0	11276 Titers (ED60) Interval 8283.0 to 15351.0	9698 Titers (ED60) Interval 7735.0 to 12159.0	9395 Titers (ED60) Interval 7726.0 to 11425.0	930 Titers (ED60) Interval 740.0 to 1168.0

SECONDARY outcome

Timeframe: At a single timepoint between 12 to 18 months post 1st vaccination

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=14 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=24 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=29 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=31 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=31 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=32 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=9 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=14 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=12 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=15 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]	2014 Titers (ED60) Interval 1190.0 to 3411.0	2034 Titers (ED60) Interval 1458.0 to 2836.0	2200 Titers (ED60) Interval 1522.0 to 3180.0	675 Titers (ED60) Interval 495.0 to 920.0	2869 Titers (ED60) Interval 1998.0 to 4119.0	3086 Titers (ED60) Interval 2143.0 to 4445.0	2960 Titers (ED60) Interval 1190.0 to 7362.0	2474 Titers (ED60) Interval 1741.0 to 3517.0	2569 Titers (ED60) Interval 1586.0 to 4160.0	969 Titers (ED60) Interval 602.0 to 1560.0

SECONDARY outcome

Timeframe: At a single timepoint between 12 to 18 months post 1st vaccination

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. Analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=38 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=41 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=46 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=40 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=46 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV A Neutralizing GMTs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]	—	2027 Titers (ED60) Interval 1546.0 to 2656.0	2302 Titers (ED60) Interval 1730.0 to 3064.0	759 Titers (ED60) Interval 588.0 to 980.0	2889 Titers (ED60) Interval 2086.0 to 4001.0	2885 Titers (ED60) Interval 2204.0 to 3778.0	—	—	—	—

SECONDARY outcome

Timeframe: At Day 31 post 2nd vaccination

Population: The analysis was performed on the PPS - Extension Study which consisted of all subjects from the ES - Extension Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=38 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=39 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=42 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=37 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=44 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV A Neutralizing GMTs at Day 31 Post 2nd Vaccination [Extension Study]	—	3892 Titers (ED60) Interval 3016.0 to 5022.0	4920 Titers (ED60) Interval 3886.0 to 6231.0	8200 Titers (ED60) Interval 6380.0 to 10539.0	5071 Titers (ED60) Interval 3848.0 to 6683.0	4779 Titers (ED60) Interval 3747.0 to 6094.0	—	—	—	—

SECONDARY outcome

Timeframe: At Screening (Day -7 to Day 1)

Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=52 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV PreF3 IgG GMCs at Screening by Each Boostrix Formulation [Primary Study]	6987 EU/mL Interval 5975.0 to 8170.0	6240 EU/mL Interval 5159.0 to 7548.0	6106 EU/mL Interval 5275.0 to 7067.0	5907 EU/mL Interval 5077.0 to 6873.0	6524 EU/mL Interval 5597.0 to 7604.0	7237 EU/mL Interval 5905.0 to 8869.0	6978 EU/mL Interval 5764.0 to 8447.0	7662 EU/mL Interval 6447.0 to 9107.0	6240 EU/mL Interval 5375.0 to 7245.0	7051 EU/mL Interval 5973.0 to 8324.0

SECONDARY outcome

Timeframe: At Day 8

Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=50 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=48 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=50 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=50 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=49 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV PreF3 IgG GMCs at Day 8 by Each Boostrix Formulation [Primary Study]	157403 EU/mL Interval 126554.0 to 195772.0	155721 EU/mL Interval 133435.0 to 181728.0	123475 EU/mL Interval 107405.0 to 141950.0	5523 EU/mL Interval 4700.0 to 6490.0	143104 EU/mL Interval 126138.0 to 162352.0	100064 EU/mL Interval 84699.0 to 118216.0	150184 EU/mL Interval 119250.0 to 189142.0	103286 EU/mL Interval 85400.0 to 124919.0	114053 EU/mL Interval 95089.0 to 136799.0	6061 EU/mL Interval 5097.0 to 7207.0

SECONDARY outcome

Timeframe: At Day 31

Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=49 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=50 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=48 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=48 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=49 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=49 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV PreF3 IgG GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	109978 EU/mL Interval 88643.0 to 136446.0	94254 EU/mL Interval 80742.0 to 110026.0	81915 EU/mL Interval 70291.0 to 95460.0	5600 EU/mL Interval 4777.0 to 6565.0	95113 EU/mL Interval 83282.0 to 108624.0	84509 EU/mL Interval 72281.0 to 98805.0	118052 EU/mL Interval 95525.0 to 145892.0	88075 EU/mL Interval 75406.0 to 102872.0	96727 EU/mL Interval 82608.0 to 113258.0	6739 EU/mL Interval 5678.0 to 7999.0

SECONDARY outcome

Timeframe: At a single timepoint between 12 to 18 months post 1st vaccination

Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=14 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=24 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=29 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=31 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=31 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=32 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) n=9 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=14 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) n=12 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) n=15 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination by Each Boostrix Formulation [Primary Study]	18127 EU/mL Interval 10969.0 to 29958.0	18832 EU/mL Interval 15141.0 to 23423.0	20720 EU/mL Interval 16689.0 to 25726.0	5014 EU/mL Interval 3932.0 to 6392.0	20894 EU/mL Interval 16466.0 to 26512.0	23189 EU/mL Interval 18629.0 to 28864.0	19641 EU/mL Interval 9143.0 to 42195.0	22905 EU/mL Interval 17801.0 to 29471.0	22233 EU/mL Interval 15931.0 to 31029.0	6811 EU/mL Interval 5005.0 to 9269.0

SECONDARY outcome

Timeframe: At a single timepoint between 12 to 18 months post 1st vaccination

Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. Analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=38 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=41 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=46 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=40 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=46 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV PreF3 IgG GMCs at Single Time Point Between 12 to 18 Months Post 1st Vaccination [Primary Study]	—	18570 EU/mL Interval 14961.0 to 23049.0	21152 EU/mL Interval 17777.0 to 25168.0	5540 EU/mL Interval 4581.0 to 6700.0	20605 EU/mL Interval 16333.0 to 25995.0	23102 EU/mL Interval 19586.0 to 27249.0	—	—	—	—

SECONDARY outcome

Timeframe: At Day 31 post 2nd vaccination

Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=38 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=39 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=42 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=37 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=44 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
RSV PreF3 IgG GMCs at Day 31 Post 2nd Vaccination [Extension Study]	—	41399 (IU/mL) Interval 34806.0 to 49241.0	45680 (IU/mL) Interval 38574.0 to 54094.0	86934 (IU/mL) Interval 75442.0 to 100177.0	42943 (IU/mL) Interval 37226.0 to 49537.0	43977 (IU/mL) Interval 38784.0 to 49865.0	—	—	—	—

SECONDARY outcome

Timeframe: At Screening (Day -7 to Day 1)

Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=52 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] anti-PT	7.17 International Units Per mL (IU/mL) Interval 4.94 to 10.41	7.39 International Units Per mL (IU/mL) Interval 5.11 to 10.68	7.55 International Units Per mL (IU/mL) Interval 5.34 to 10.66	5.66 International Units Per mL (IU/mL) Interval 4.06 to 7.88	7.64 International Units Per mL (IU/mL) Interval 5.47 to 10.66	6.65 International Units Per mL (IU/mL) Interval 4.66 to 9.47	—	—	—	—
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] anti-FHA	28 International Units Per mL (IU/mL) Interval 21.0 to 37.4	32.8 International Units Per mL (IU/mL) Interval 23.0 to 46.7	31 International Units Per mL (IU/mL) Interval 22.7 to 42.4	29.6 International Units Per mL (IU/mL) Interval 22.5 to 38.9	34.5 International Units Per mL (IU/mL) Interval 24.3 to 49.1	29.3 International Units Per mL (IU/mL) Interval 22.0 to 38.9	—	—	—	—
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening by Each Boostrix Formulation [Primary Study] anti-PRN	28.7 International Units Per mL (IU/mL) Interval 17.9 to 46.1	43.2 International Units Per mL (IU/mL) Interval 27.9 to 66.7	42.1 International Units Per mL (IU/mL) Interval 27.6 to 64.2	40.1 International Units Per mL (IU/mL) Interval 26.9 to 60.0	39 International Units Per mL (IU/mL) Interval 25.3 to 60.1	28.1 International Units Per mL (IU/mL) Interval 18.2 to 43.4	—	—	—	—

SECONDARY outcome

Timeframe: At Day 31

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=49 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=48 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] anti-PT	44.99 (IU/mL) Interval 34.81 to 58.15	57.36 (IU/mL) Interval 41.82 to 78.69	43.76 (IU/mL) Interval 34.1 to 56.17	36.98 (IU/mL) Interval 28.25 to 48.42	54.95 (IU/mL) Interval 44.78 to 67.44	79.16 (IU/mL) Interval 62.67 to 99.98	—	—	—	—
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] anti-FHA	232.9 (IU/mL) Interval 182.2 to 297.8	237.1 (IU/mL) Interval 194.1 to 289.5	186.5 (IU/mL) Interval 149.8 to 232.3	176.7 (IU/mL) Interval 139.3 to 224.1	210.6 (IU/mL) Interval 168.5 to 263.1	303.6 (IU/mL) Interval 241.6 to 381.5	—	—	—	—
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 by Each Boostrix Formulation [Primary Study] anti-PRN	331.4 (IU/mL) Interval 238.4 to 460.5	309.5 (IU/mL) Interval 226.7 to 422.6	217.7 (IU/mL) Interval 153.7 to 308.3	228.1 (IU/mL) Interval 161.9 to 321.5	214.7 (IU/mL) Interval 166.8 to 276.4	395.1 (IU/mL) Interval 290.3 to 537.6	—	—	—	—

SECONDARY outcome

Timeframe: At Screening (Day -7 to Day 1)

Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=50 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=52 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=49 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study]	0.58 (IU/mL) Interval 0.43 to 0.78	0.26 (IU/mL) Interval 0.18 to 0.39	0.46 (IU/mL) Interval 0.33 to 0.64	0.55 (IU/mL) Interval 0.42 to 0.73	0.27 (IU/mL) Interval 0.17 to 0.42	0.23 (IU/mL) Interval 0.16 to 0.32	—	—	—	—

SECONDARY outcome

Timeframe: At Day 31

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=49 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=47 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=48 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=48 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	3.29 (IU/mL) Interval 2.62 to 4.14	1.3 (IU/mL) Interval 0.97 to 1.73	2.11 (IU/mL) Interval 1.61 to 2.76	2.2 (IU/mL) Interval 1.72 to 2.81	1.18 (IU/mL) Interval 0.85 to 1.63	1.76 (IU/mL) Interval 1.25 to 2.48	—	—	—	—

SECONDARY outcome

Timeframe: At Screening (Day -7 to Day 1)

Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum).

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=51 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=52 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=51 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Tetanus (Anti-T) GMCs at Screening by Each Boostrix Formulation [Primary Study]	1.68 (IU/mL) Interval 1.29 to 2.19	1.14 (IU/mL) Interval 0.87 to 1.5	1.35 (IU/mL) Interval 1.01 to 1.81	1.56 (IU/mL) Interval 1.27 to 1.92	1.1 (IU/mL) Interval 0.78 to 1.54	0.88 (IU/mL) Interval 0.64 to 1.22	—	—	—	—

SECONDARY outcome

Timeframe: At Day 31

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) n=49 Participants Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) n=49 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=51 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=48 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Tetanus (Anti-T) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]	8.32 (IU/mL) Interval 6.88 to 10.05	5.57 (IU/mL) Interval 4.64 to 6.7	6.09 (IU/mL) Interval 4.98 to 7.45	6.27 (IU/mL) Interval 5.29 to 7.44	5.3 (IU/mL) Interval 4.52 to 6.21	6.74 (IU/mL) Interval 5.79 to 7.84	—	—	—	—

SECONDARY outcome

Timeframe: At Screening (Day -7 to Day 1)

Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=100 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=103 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=102 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] Anti-PT	—	7.47 IU/mL Interval 5.83 to 9.57	—	—	6.56 IU/mL Interval 5.2 to 8.28	6.90 IU/mL Interval 5.36 to 8.89	—	—	—	—
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] Anti-FHA	—	31.9 IU/mL Interval 25.3 to 40.2	—	—	31.9 IU/mL Interval 25.6 to 39.8	28.6 IU/mL Interval 23.5 to 34.9	—	—	—	—
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Screening [Primary Study] Anti-PRN	—	42.6 IU/mL Interval 31.6 to 57.4	—	—	39.6 IU/mL Interval 29.6 to 52.9	28.4 IU/mL Interval 20.7 to 38.9	—	—	—	—

SECONDARY outcome

Timeframe: At Day 31

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=98 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=102 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=97 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] Anti-PT	—	50.10 IU/mL Interval 41.04 to 61.17	—	—	45.08 IU/mL Interval 38.0 to 53.48	59.51 IU/mL Interval 49.71 to 71.23	—	—	—	—
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] Anti-FHA	—	210.3 IU/mL Interval 181.4 to 243.8	—	—	192.9 IU/mL Interval 164.2 to 226.6	265.6 IU/mL Interval 224.7 to 313.8	—	—	—	—
Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) GMCs at Day 31 [Primary Study] Anti-PRN	—	259.6 IU/mL Interval 205.8 to 327.4	—	—	221.3 IU/mL Interval 179.5 to 272.9	361.1 IU/mL Interval 289.1 to 451.1	—	—	—	—

SECONDARY outcome

Timeframe: At Screening (Day -7 to Day 1)

Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=98 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=103 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=99 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Diphtheria (Anti-D) GMCs at Screening [Primary Study]	—	0.35 IU/mL Interval 0.27 to 0.45	—	—	0.39 IU/mL Interval 0.3 to 0.51	0.36 IU/mL Interval 0.28 to 0.47	—	—	—	—

SECONDARY outcome

Timeframe: At Day 31

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=96 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=99 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=97 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Diphtheria (Anti-D) GMCs at Day 31 [Primary Study]	—	1.65 IU/mL Interval 1.35 to 2.01	—	—	1.59 IU/mL Interval 1.29 to 1.97	2.42 IU/mL Interval 1.96 to 2.99	—	—	—	—

SECONDARY outcome

Timeframe: At Screening (Day -7 to Day 1)

Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=100 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=103 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=102 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Tetanus (Anti-T) GMCs at Screening [Primary Study]	—	1.24 IU/mL Interval 1.02 to 1.51	—	—	1.31 IU/mL Interval 1.08 to 1.6	1.22 IU/mL Interval 0.98 to 1.51	—	—	—	—

SECONDARY outcome

Timeframe: At Day 31

Outcome measures

Outcome measures
Measure	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(Pooled) n=98 Participants Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_dTpa_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(EX-US) n=102 Participants Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(EX-US) n=97 Participants Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(US) Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(US) Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(US) Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Tetanus (Anti-T) GMCs at Day 31 [Primary Study]	—	5.83 IU/mL Interval 5.1 to 6.66	—	—	5.76 IU/mL Interval 5.13 to 6.47	7.49 IU/mL Interval 6.64 to 8.46	—	—	—	—

Adverse Events

RSV120_dTpa_RSV120(Pooled)

Serious events: 1 serious events

Other events: 92 other events

Deaths: 0 deaths

RSV120_Placebo_RSV120(Pooled)

Serious events: 0 serious events

Other events: 90 other events

Deaths: 0 deaths

RSV60_dTpa_RSV120(Pooled)

Serious events: 0 serious events

Other events: 91 other events

Deaths: 0 deaths

RSV60_Placebo_RSV120(Pooled)

Serious events: 1 serious events

Other events: 82 other events

Deaths: 0 deaths

dTpa_Placebo_RSV120(Pooled)

Serious events: 0 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RSV120_dTpa_RSV120(Pooled) n=101 participants at risk Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(Pooled) n=101 participants at risk Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(Pooled) n=103 participants at risk Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(Pooled) n=102 participants at risk Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(Pooled) n=102 participants at risk Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Injury, poisoning and procedural complications Radius fracture	0.99% 1/101 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Injury, poisoning and procedural complications Ulna fracture	0.99% 1/101 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Injury, poisoning and procedural complications Wrist fracture	0.99% 1/101 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Pyelonephritis	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).

Other adverse events

Other adverse events
Measure	RSV120_dTpa_RSV120(Pooled) n=101 participants at risk Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV120_Placebo_RSV120(Pooled) n=101 participants at risk Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_dTpa_RSV120(Pooled) n=103 participants at risk Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	RSV60_Placebo_RSV120(Pooled) n=102 participants at risk Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.	dTpa_Placebo_RSV120(Pooled) n=102 participants at risk Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
General disorders Injection site pain - Primary Study	85.1% 86/101 • Number of events 204 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	61.4% 62/101 • Number of events 136 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	81.6% 84/103 • Number of events 200 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	58.8% 60/102 • Number of events 128 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	79.4% 81/102 • Number of events 170 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Fatigue - Primary Study	41.6% 42/101 • Number of events 86 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	39.6% 40/101 • Number of events 83 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	37.9% 39/103 • Number of events 79 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	33.3% 34/102 • Number of events 69 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	37.3% 38/102 • Number of events 77 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site erythema - Primary Study	6.9% 7/101 • Number of events 18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	5.9% 6/101 • Number of events 12 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	7.8% 8/103 • Number of events 18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	6.9% 7/102 • Number of events 14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	5.9% 6/102 • Number of events 12 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site swelling - Primary Study	5.0% 5/101 • Number of events 12 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	7.9% 8/101 • Number of events 16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.9% 3/103 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	5.9% 6/102 • Number of events 12 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	3.9% 4/102 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Pyrexia - Primary Study	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	4.0% 4/101 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.9% 3/103 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	3.9% 4/102 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	6.9% 7/102 • Number of events 14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site bruising - Primary Study	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/101 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	3.9% 4/103 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Administration site pain - Primary Study	2.0% 2/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.9% 3/103 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Administration site erythema - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	3.0% 3/101 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	3.9% 4/103 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site pruritus - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.9% 3/102 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Administration site swelling - Primary Study	0.99% 1/101 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	3.9% 4/103 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site haemorrhage - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Vaccination site nodule - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	1.9% 2/103 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Malaise - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Pain - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site warmth - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Axillary pain - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Chills - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site induration - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Influenza like illness - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Feeling cold - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Hangover - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site discomfort - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site haematoma - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site discolouration - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site rash - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Headache - Primary Study	46.5% 47/101 • Number of events 105 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	46.5% 47/101 • Number of events 101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	36.9% 38/103 • Number of events 81 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	41.2% 42/102 • Number of events 92 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	36.3% 37/102 • Number of events 76 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Dizziness - Primary Study	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Disturbance in attention - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Migraine - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Sciatica - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Head discomfort - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Neuralgia - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Sleep deficit - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Post-traumatic headache - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Gastrointestinal disorder - Primary Study	23.8% 24/101 • Number of events 50 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	28.7% 29/101 • Number of events 60 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	27.2% 28/103 • Number of events 57 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	28.4% 29/102 • Number of events 58 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	27.5% 28/102 • Number of events 56 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Nausea - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Dyspepsia - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Toothache - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Abdominal distension - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Diarrhoea - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Hyperchlorhydria - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Abdominal pain - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Upper respiratory tract infection - Primary Study	7.9% 8/101 • Number of events 16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	8.9% 9/101 • Number of events 18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	3.9% 4/103 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	4.9% 5/102 • Number of events 10 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Nasopharyngitis - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	6.9% 7/102 • Number of events 14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.9% 3/102 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Urinary tract infection - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Sinusitis - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.9% 3/102 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Rhinitis - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Gastroenteritis - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Pharyngitis - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Tooth infection - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Conjunctivitis - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Pharyngitis bacterial - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Pharyngitis streptococcal - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Viral infection - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Bacterial vaginosis - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Chlamydial infection - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Cystitis - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Ear infection - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Gingivitis - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Oral herpes - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Otitis media - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Otitis media acute - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Vaginitis chlamydial - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Vulvovaginal mycotic infection - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Myalgia - Primary Study	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	4.0% 4/101 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	3.9% 4/102 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Back pain - Primary Study	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Neck pain - Primary Study	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Arthralgia - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Muscle tightness - Primary Study	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Pain in extremity - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Musculoskeletal pain - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Pain in jaw - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain - Primary Study	3.0% 3/101 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/101 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Respiratory, thoracic and mediastinal disorders Cough - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Respiratory, thoracic and mediastinal disorders Nasal congestion - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	1.9% 2/103 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Skin and subcutaneous tissue disorders Rash - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Skin and subcutaneous tissue disorders Dermatitis - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Skin and subcutaneous tissue disorders Dermatitis allergic - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Skin and subcutaneous tissue disorders Night sweats - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Blood and lymphatic system disorders Lymphadenopathy - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	1.9% 2/103 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.0% 2/102 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Blood and lymphatic system disorders Lymphadenitis - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Injury, poisoning and procedural complications Procedural pain - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Injury, poisoning and procedural complications Thermal burn - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Reproductive system and breast disorders Dysmenorrhoea - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Reproductive system and breast disorders Intermenstrual bleeding - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Reproductive system and breast disorders Vaginal discharge - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Psychiatric disorders Insomnia - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.97% 1/103 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Immune system disorders Drug hypersensitivity - Primary Study	0.99% 1/101 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Cardiac disorders Palpitations - Primary Study	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/101 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/103 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.98% 1/102 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/102 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site pain - Extension Study	87.2% 34/39 • Number of events 68 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	87.8% 36/41 • Number of events 74 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	80.4% 37/46 • Number of events 74 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	85.4% 35/41 • Number of events 70 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	39.1% 18/46 • Number of events 38 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Fatigue - Extension Study	25.6% 10/39 • Number of events 23 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	36.6% 15/41 • Number of events 31 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	37.0% 17/46 • Number of events 35 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	46.3% 19/41 • Number of events 39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	34.8% 16/46 • Number of events 32 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site erythema - Extension Study	17.9% 7/39 • Number of events 14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	9.8% 4/41 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	8.7% 4/46 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	14.6% 6/41 • Number of events 12 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site swelling - Extension Study	12.8% 5/39 • Number of events 10 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	7.3% 3/41 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	8.7% 4/46 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	4.9% 2/41 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Pyrexia - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	12.2% 5/41 • Number of events 10 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site pruritus - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	4.9% 2/41 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Malaise - Extension Study	2.6% 1/39 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Administration site pain - Extension Study	2.6% 1/39 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site induration - Extension Study	2.6% 1/39 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Inflammation - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Influenza like illness - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site haemorrhage - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Pain - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Administration site swelling - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
General disorders Injection site lymphadenopathy - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Headache - Extension Study	28.2% 11/39 • Number of events 24 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	36.6% 15/41 • Number of events 31 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	32.6% 15/46 • Number of events 32 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	56.1% 23/41 • Number of events 50 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	34.8% 16/46 • Number of events 34 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Nervous system disorders Migraine with aura - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Gastrointestinal disorder - Extension Study	10.3% 4/39 • Number of events 9 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	24.4% 10/41 • Number of events 20 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	15.2% 7/46 • Number of events 14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	24.4% 10/41 • Number of events 20 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	15.2% 7/46 • Number of events 14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Oesophageal spasm - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Abdominal pain - Extension Study	2.6% 1/39 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Diarrhoea - Extension Study	2.6% 1/39 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Gastrointestinal disorders Vomiting - Extension Study	2.6% 1/39 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Pharyngitis - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	4.9% 2/41 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Nasopharyngitis - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Bronchitis - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Ear infection - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Gastroenteritis - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Pyelonephritis - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Tonsillitis - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Respiratory tract infection - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Sinusitis - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Infections and infestations Upper respiratory tract infection - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	7.3% 3/41 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Respiratory, thoracic and mediastinal disorders Nasal congestion - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Limb discomfort - Extension Study	2.6% 1/39 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Myalgia - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Musculoskeletal and connective tissue disorders Arthralgia - Extension Study	2.6% 1/39 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Injury, poisoning and procedural complications Muscle strain - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Injury, poisoning and procedural complications Contusion - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Psychiatric disorders Affect lability - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Psychiatric disorders Poor quality sleep - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Skin and subcutaneous tissue disorders Night sweats - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Skin and subcutaneous tissue disorders Rash - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Ear and labyrinth disorders Ear pain - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Reproductive system and breast disorders Dysmenorrhoea - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.4% 1/41 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Eye disorders Vision blurred - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Immune system disorders Seasonal allergy - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).
Vascular disorders Hypertension - Extension Study	0.00% 0/39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/46 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	0.00% 0/41 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).	2.2% 1/46 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 (Primary Study) to the Study End (Day 181 after the second RSVPreF3 vaccination, Extension Study). As per the analysis plan, AEs were reported for the RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV60\_Placebo\_RSV120(Pooled) \& dTpa\_Placebo\_RSV120(Pooled) groups, as the 2 formulations of dTpa vaccine (300 μg/500 μg) showed similar safety profiles in previous studies.Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary \& Extension Study).

Additional Information

GSK Response Center

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.
Publication restrictions are in place

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