RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults

A Randomized, Single-blind, Placebo Controlled, Dose-ranging Phase II Trial in ≥ 55 Year Old Adults to Evaluate the Safety and Immunogenicity of the Recombinant MVA-BN-RSV Vaccine

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02873286

Enrollment

420

Registered

2016-08-19

Start date

2016-09-30

Completion date

2018-12-31

Last updated

2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

Keywords

RSV Vaccines, Respiratory Syncytial Virus Vaccines

Brief summary

A total of 400 subjects will be recruited into five treatment subject groups à 80 subjects.Subject will receive two administrations 4 weeks apart which will consist of MVA-BN-RSV Dose 1, MVA-BN-RSV Dose 2 or Placebo (TBS). 86 subjects from 2 treatment groups (43 per treatment group) are supposed to receive one (booster) dose of MVA-BN-RSV vaccine approximately one year after their first vaccination. In this booster substudy, eligible subjects will receive the same dose they received during the main trial.

Interventions

BIOLOGICALMVA-BN-RSV

MVA-mBN294B

OTHERPlacebo

Tris Buffered Saline, sterile

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

(Main study): 1. Male and female subjects, ≥ 55 years of age. 2. Prior to performance of any trial specific procedures, the subject has read, signed and dated an informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject, and has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization form. 3. Subjects without symptomatic cardiopulmonary and/or metabolic disease. Note that subjects who have any active symptoms related to cardiac and/or pulmonary and/or metabolic disease (including e.g. uncontrolled asthma, angina pectoris, hyperglycaemia or other episodic symptoms), or who receive ongoing therapy to control current, active symptoms, are not eligible. Subjects on stable treatment (no change in ≥ 1 month) for previous and controlled symptoms or conditions are eligible. The following are examples of subjects who may bear cardiopulmonary or metabolic diagnoses but who would remain eligible: * Subjects on stable (no change in ≥ 1 month) therapy for findings (e.g. hypertension, hyperlipidemia) which are not associated with current symptoms or disability. * Subjects with type II diabetes mellitus are considered eligible as long as they are stable on oral antidiabetics and have either a documented glycated hemoglobin (HbA1c) of ≤ 8 % within three months prior to trial participation or confirmation of controlled blood glucose level must be obtained at the SCR (screening) visit by a lab test. * Subjects who receive short term treatment for temporary conditions. * Other clinically insignificant findings not deemed to be associated with increased risk for respiratory viral infections as determined by the investigator. 4. Able to comply with trial requirements; including access to transportation for trial visits. 5. Body mass index (BMI) ≥ 18.5 and ≤ 39.9 BMI formula for pounds and inches: BMI = (bodyweight in pounds) \* 703 (bodyheight in inches)2 6. Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for at least 30 days prior to the first vaccination, must agree to use an acceptable method of contraception (as defined in Section 8.2.11) during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination 7. Not clinically significant laboratory values as defined in the protocol, excluding any Grade ≥ 3 toxicity. 8. Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody test to hepatitis C virus. 9. Electrocardiogram (ECG) without clinically significant acute findings (e.g. findings suggestive of current ischemia, ventricular arrhythmias, congestive heart failure and ventricular hypertrophy).

Exclusion criteria

(Main Study): 1. Pregnant or breast-feeding women. 2. Uncontrolled serious infection, i.e. not responding to antimicrobial therapy. 3. History or current clinical manifestation of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject or would limit the subject's ability to complete the trial. * History of cerebrovascular disorders, including stroke. Patients with history of transient ischaemic attack (TIA) ≥ 1 year prior to trial participation remain eligible. * History of myocardial infarction within ≤ 1 year prior to trial participation, current clinical manifestation of angina pectoris, current clinical manifestation of congestive heart failure ≥ New York Heart Association (NYHA) Grade II, uncontrolled high blood pressure defined as systolic blood pressure ≥ 150 mmHg and/or diastolic ≥ 100 mmHg within the last 2 months. 4. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. Persons with rheumatoid arthritis not requiring immunomodulatory and/or immunosuppressant treatment are not excluded. 5. Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I. 6. History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months ago that is considered to have achieved cure. Subjects with history of skin cancer should not be vaccinated at the previous tumor site. 7. Clinically significant mental disorder, not adequately controlled by medical treatment. 8. Active or recent (within the time period of six months before trial participation) history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse. 9. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. tris(hydroxymethyl)-amino methane, chicken embryo fibroblast proteins, gentamycin. 10. Known allergy to eggs or aminoglycosides. 11. History of anaphylaxis or severe allergic reaction to any vaccine. 12. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination. 13. Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination. 14. Chronic systemic administration (defined as more than 14 days) of \> 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from three months prior to first administration of the trial vaccination and ending at the last visit of the active trial phase. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted. 15. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to first administration of the trial vaccination and ending at the last visit of the active trial phase. 16. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first trial vaccination, or planned administration of such a drug between participation in the trial and until 4 weeks after last trial vaccination. 17. Previous or planned vaccination with a RSV vaccine/vaccine candidate. 18. Clinical trial personnel working on the current trial. Inclusion Criteria (Substudy): 1. Prior to performance of any booster substudy specific procedures, the subject has read, signed and dated an informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject. 2. Subject has completed all vaccinations of the main trial according to protocol.

Design outcomes

Primary

Measure	Time frame	Description
PRNT (Subtype A) GMT	Week 6 (Main Study) i.e., 2 weeks following the second vaccination	Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

Secondary

Measure	Time frame	Description
Percentage of Participants With Response by PRNT (Subtype A)	within 108 weeks	Response rate based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Response is defined as the appearance of antibody titers ≥ detection limit (20) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.
PRNT (Subtype B) GMT	within 108 weeks	Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)
Percentage of Participants With Response by PRNT (Subtype B)	within 108 weeks	Response rate based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Response is defined as the appearance of antibody titers ≥ detection limit (20) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.
ELISA (IgG) GMT	within 108 weeks	Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '31.5' (i.e. 1/2 DL)
Percentage of Participants With Response by IgG ELISA	within 108 weeks	Response rate based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (63) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.
ELISA (IgA) GMT	within 108 weeks	Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '50' (i.e. 1/2 DL)
Percentage of Participants With Response by IgA ELISA	within 108 weeks	Response rate based on RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (100) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.
ELISA (Mucosal IgA) GMT	within 82 weeks	Geometric Mean Titers (GMTs) based on mucosal RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '1' (i.e. 1/2 DL)
Percentage of Participants With Response by Mucosal IgA ELISA	within 82 weeks	Response rate based on mucosal RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (2) for initially negative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.
ELISPOT (IFN-g, Peptide Pool: F) GMSFU	within 58 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)
ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	within 58 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)
ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	within 58 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)
ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	within 58 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)
ELISPOT (IFN-g, Peptide Pool: N) GMSFU	within 58 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)
ELISPOT (IL-4, Peptide Pool: F) GMSFU	within 58 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)
ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	within 58 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)
ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	within 58 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)
ELISPOT (IL-4, Peptide Pool: M2) GMSFU	within 58 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)
ELISPOT (IL-4, Peptide Pool: N) GMSFU	within 58 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	within 58 weeks	Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	within 58 weeks	Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	within 58 weeks	Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	within 58 weeks	Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	within 58 weeks	Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	within 58 weeks	Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	within 58 weeks	Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	within 58 weeks	Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	within 58 weeks	Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	within 58 weeks	Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.
Memory B Cells (IgG) GMSFU	within 82 weeks	Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Immunoglobulin G (IgG)-producing memory B cells. Negative results (i.e. results below 0.01) are included with a value of '0.005'
Serious Adverse Events	within 108 weeks (Main Study + Booster Substudy)	Number of participants reporting Serious Adverse Events per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts \[retrospectively collected in booster substudy\], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.
Related Serious Adverse Events	within 108 weeks (Main Study + Booster Substudy)	Number of participants reporting Serious Adverse Events possibly, probably or definitely related to the trial vaccine per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts \[retrospectively collected in booster substudy\], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.
Grade ≥ 3 Serious Adverse Events	within 108 weeks (Main Study + Booster Substudy)	Number of participants reporting Serious Adverse Events with intensity ≥ Grade 3 per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts \[retrospectively collected in booster substudy\], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.
Related Grade ≥ 3 Adverse Events	within 29 days after vaccination	Number of participants reporting Adverse Events possibly, probably or definitely related to the trial vaccine with intensity ≥ Grade 3 per period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Pooled solicited (general only) and unsolicited AEs. Percentages based on number of subjects still in the study at the start of the respective period.
Solicited Local Adverse Events	within 8 days after vaccination	Incidence of injection site reactions (solicited via diary cards) after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.
Grade ≥ 3 Solicited Local Adverse Events	within 8 days after vaccination	Incidence of injection site reactions (solicited via diary cards) with intensity ≥ Grade 3 after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.
Solicited General Adverse Events	within 8 days after vaccination	Incidence of systemic reactions (solicited via diary cards) after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.
PRNT (Subtype A) GMT	within 108 weeks	Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)
Related Solicited General Adverse Events	within 8 days after vaccination	Incidence of systemic reactions (solicited via diary cards) possibly, probably or definitely related to the trial vaccine after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.
Unsolicited Non-serious Adverse Events	within 29 days after vaccination	Incidence of unsolicited non-serious adverse events by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.
Related Unsolicited Non-serious Adverse Events	within 29 days after vaccination	Incidence of unsolicited non-serious adverse events possibly, probably or definitely related to the trial vaccine by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.
Grade ≥ 3 Unsolicited Non-serious Adverse Events	within 29 days after vaccination	Incidence of unsolicited non-serious adverse events with intensity ≥ Grade 3 by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.
Grade ≥ 3 Solicited General Adverse Events	within 8 days after vaccination	Incidence of systemic reactions (solicited via diary cards) with intensity ≥ Grade 3 after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Group 1 - Single Low Dose / Booster First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	78
Group 2 - Two Low Doses First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	89
Group 3 - Single High Dose / Booster First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	80
Group 4 - Two High Doses First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	90
Group 5 - Placebo First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	83
Total	420

Baseline characteristics

Characteristic	Group 1 - Single Low Dose / Booster	Group 2 - Two Low Doses	Group 3 - Single High Dose / Booster	Group 4 - Two High Doses	Group 5 - Placebo	Total
Age, Continuous	65.1 years STANDARD_DEVIATION 8.09	64.8 years STANDARD_DEVIATION 7.78	65.3 years STANDARD_DEVIATION 7.18	65.0 years STANDARD_DEVIATION 7.93	65.6 years STANDARD_DEVIATION 7.2	65.2 years STANDARD_DEVIATION 7.62
Age, Customized 55 to 69 years	53 Participants	61 Participants	56 Participants	63 Participants	56 Participants	289 Participants
Age, Customized >=70 years	25 Participants	28 Participants	24 Participants	27 Participants	27 Participants	131 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	7 Participants	1 Participants	4 Participants	1 Participants	16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants	82 Participants	79 Participants	86 Participants	82 Participants	404 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Race (NIH/OMB) Asian	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) Black or African American	9 Participants	15 Participants	14 Participants	21 Participants	11 Participants	70 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	69 Participants	69 Participants	66 Participants	69 Participants	71 Participants	344 Participants
Region of Enrollment United States	78 participants	89 participants	80 participants	90 participants	83 participants	420 participants
Sex: Female, Male Female	47 Participants	56 Participants	49 Participants	59 Participants	48 Participants	259 Participants
Sex: Female, Male Male	31 Participants	33 Participants	31 Participants	31 Participants	35 Participants	161 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 78	0 / 89	0 / 80	0 / 90	0 / 83
other Total, other adverse events	15 / 78	23 / 89	20 / 80	28 / 90	27 / 83
serious Total, serious adverse events	4 / 78	4 / 89	4 / 80	2 / 90	5 / 83

Outcome results

Primary

PRNT (Subtype A) GMT

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

Time frame: Week 6 (Main Study) i.e., 2 weeks following the second vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. Calculations based on participants with data available for this outcome.

Arm	Measure	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	300.5 Titer
Group 2 - Two Low Doses	PRNT (Subtype A) GMT	278.9 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	311.9 Titer
Group 4 - Two High Doses	PRNT (Subtype A) GMT	373.3 Titer
Group 5 - Placebo	PRNT (Subtype A) GMT	229.3 Titer

Secondary

ELISA (IgA) GMT

Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '50' (i.e. 1/2 DL)

Time frame: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 82 (Booster Follow-Up 2)	711.0 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 30 (Follow-Up 2)	675.3 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Individual Peak (Main Study)	1511.0 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 4 (Main Study)	1061.3 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 0 (Main Study)	581.7 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 60 (Booster Substudy)	941.3 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 58 (Booster Substudy)	1235.2 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 6 (Main Study)	1001.3 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 108 (Booster Follow-Up 3)	619.1 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 56 (Booster Substudy)	627.3 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 8 (Main Study)	887.3 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 2 (Main Study)	1377.7 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 16 (Follow-Up 1)	745.3 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Week 68 (Booster Follow-Up 1)	734.4 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgA) GMT	Individual Peak (Booster Substudy)	1261.3 Titer
Group 2 - Two Low Doses	ELISA (IgA) GMT	Individual Peak (Main Study)	1696.5 Titer
Group 2 - Two Low Doses	ELISA (IgA) GMT	Week 30 (Follow-Up 2)	743.5 Titer
Group 2 - Two Low Doses	ELISA (IgA) GMT	Week 16 (Follow-Up 1)	709.8 Titer
Group 2 - Two Low Doses	ELISA (IgA) GMT	Week 4 (Main Study)	1120.8 Titer
Group 2 - Two Low Doses	ELISA (IgA) GMT	Week 2 (Main Study)	1373.3 Titer
Group 2 - Two Low Doses	ELISA (IgA) GMT	Week 0 (Main Study)	591.1 Titer
Group 2 - Two Low Doses	ELISA (IgA) GMT	Week 8 (Main Study)	1045.1 Titer
Group 2 - Two Low Doses	ELISA (IgA) GMT	Week 6 (Main Study)	1248.3 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Individual Peak (Booster Substudy)	1511.0 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 0 (Main Study)	776.3 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 2 (Main Study)	2593.6 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 4 (Main Study)	1763.0 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 6 (Main Study)	1538.8 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 8 (Main Study)	1459.2 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Individual Peak (Main Study)	2795.1 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 16 (Follow-Up 1)	1001.6 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 30 (Follow-Up 2)	1089.5 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 56 (Booster Substudy)	719.4 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 58 (Booster Substudy)	1480.5 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 60 (Booster Substudy)	1099.0 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 68 (Booster Follow-Up 1)	853.3 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 82 (Booster Follow-Up 2)	838.1 Titer
Group 3 - Single High Dose / Booster	ELISA (IgA) GMT	Week 108 (Booster Follow-Up 3)	716.7 Titer
Group 4 - Two High Doses	ELISA (IgA) GMT	Week 30 (Follow-Up 2)	970.3 Titer
Group 4 - Two High Doses	ELISA (IgA) GMT	Week 2 (Main Study)	1922.8 Titer
Group 4 - Two High Doses	ELISA (IgA) GMT	Week 0 (Main Study)	623.3 Titer
Group 4 - Two High Doses	ELISA (IgA) GMT	Week 4 (Main Study)	1378.1 Titer
Group 4 - Two High Doses	ELISA (IgA) GMT	Individual Peak (Main Study)	2331.1 Titer
Group 4 - Two High Doses	ELISA (IgA) GMT	Week 16 (Follow-Up 1)	933.2 Titer
Group 4 - Two High Doses	ELISA (IgA) GMT	Week 8 (Main Study)	1367.3 Titer
Group 4 - Two High Doses	ELISA (IgA) GMT	Week 6 (Main Study)	1592.9 Titer
Group 5 - Placebo	ELISA (IgA) GMT	Individual Peak (Main Study)	777.0 Titer
Group 5 - Placebo	ELISA (IgA) GMT	Week 30 (Follow-Up 2)	676.3 Titer
Group 5 - Placebo	ELISA (IgA) GMT	Week 6 (Main Study)	608.8 Titer
Group 5 - Placebo	ELISA (IgA) GMT	Week 16 (Follow-Up 1)	573.8 Titer
Group 5 - Placebo	ELISA (IgA) GMT	Week 4 (Main Study)	614.9 Titer
Group 5 - Placebo	ELISA (IgA) GMT	Week 2 (Main Study)	619.8 Titer
Group 5 - Placebo	ELISA (IgA) GMT	Week 8 (Main Study)	590.8 Titer
Group 5 - Placebo	ELISA (IgA) GMT	Week 0 (Main Study)	585.4 Titer

Secondary

ELISA (IgG) GMT

Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '31.5' (i.e. 1/2 DL)

Time frame: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 6 (Main Study)	2671.0 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 16 (Follow-Up 1)	2833.4 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 108 (Booster Follow-Up 3)	2083.1 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 58 (Booster Substudy)	3878.2 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 56 (Booster Substudy)	2501.8 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 8 (Main Study)	2653.4 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Individual Peak (Main Study)	3266.2 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 2 (Main Study)	2506.9 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 82 (Booster Follow-Up 2)	2568.9 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 68 (Booster Follow-Up 1)	3031.5 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 4 (Main Study)	2599.9 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 30 (Follow-Up 2)	2162.3 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 0 (Main Study)	1578.4 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Individual Peak (Booster Substudy)	4445.5 Titer
Group 1 - Single Low Dose / Booster	ELISA (IgG) GMT	Week 60 (Booster Substudy)	4139.6 Titer
Group 2 - Two Low Doses	ELISA (IgG) GMT	Week 4 (Main Study)	2559.9 Titer
Group 2 - Two Low Doses	ELISA (IgG) GMT	Individual Peak (Main Study)	3412.2 Titer
Group 2 - Two Low Doses	ELISA (IgG) GMT	Week 2 (Main Study)	2460.0 Titer
Group 2 - Two Low Doses	ELISA (IgG) GMT	Week 16 (Follow-Up 1)	2965.0 Titer
Group 2 - Two Low Doses	ELISA (IgG) GMT	Week 0 (Main Study)	1488.6 Titer
Group 2 - Two Low Doses	ELISA (IgG) GMT	Week 30 (Follow-Up 2)	2107.5 Titer
Group 2 - Two Low Doses	ELISA (IgG) GMT	Week 6 (Main Study)	2964.1 Titer
Group 2 - Two Low Doses	ELISA (IgG) GMT	Week 8 (Main Study)	2960.1 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 108 (Booster Follow-Up 3)	2260.0 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 0 (Main Study)	1636.1 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 2 (Main Study)	3773.6 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 4 (Main Study)	3884.6 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 6 (Main Study)	3864.3 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 8 (Main Study)	3773.6 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Individual Peak (Main Study)	4824.0 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 16 (Follow-Up 1)	3294.5 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 30 (Follow-Up 2)	2796.5 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 56 (Booster Substudy)	2816.4 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 58 (Booster Substudy)	4261.7 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 60 (Booster Substudy)	4368.3 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Individual Peak (Booster Substudy)	4788.9 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 68 (Booster Follow-Up 1)	3250.5 Titer
Group 3 - Single High Dose / Booster	ELISA (IgG) GMT	Week 82 (Booster Follow-Up 2)	2754.0 Titer
Group 4 - Two High Doses	ELISA (IgG) GMT	Week 30 (Follow-Up 2)	3023.4 Titer
Group 4 - Two High Doses	ELISA (IgG) GMT	Week 6 (Main Study)	4270.0 Titer
Group 4 - Two High Doses	ELISA (IgG) GMT	Week 2 (Main Study)	3639.5 Titer
Group 4 - Two High Doses	ELISA (IgG) GMT	Individual Peak (Main Study)	5061.4 Titer
Group 4 - Two High Doses	ELISA (IgG) GMT	Week 4 (Main Study)	3697.0 Titer
Group 4 - Two High Doses	ELISA (IgG) GMT	Week 16 (Follow-Up 1)	3950.8 Titer
Group 4 - Two High Doses	ELISA (IgG) GMT	Week 8 (Main Study)	4283.2 Titer
Group 4 - Two High Doses	ELISA (IgG) GMT	Week 0 (Main Study)	1819.5 Titer
Group 5 - Placebo	ELISA (IgG) GMT	Individual Peak (Main Study)	2207.2 Titer
Group 5 - Placebo	ELISA (IgG) GMT	Week 30 (Follow-Up 2)	1777.6 Titer
Group 5 - Placebo	ELISA (IgG) GMT	Week 6 (Main Study)	1766.6 Titer
Group 5 - Placebo	ELISA (IgG) GMT	Week 2 (Main Study)	1674.3 Titer
Group 5 - Placebo	ELISA (IgG) GMT	Week 8 (Main Study)	1844.6 Titer
Group 5 - Placebo	ELISA (IgG) GMT	Week 0 (Main Study)	1672.2 Titer
Group 5 - Placebo	ELISA (IgG) GMT	Week 4 (Main Study)	1747.3 Titer
Group 5 - Placebo	ELISA (IgG) GMT	Week 16 (Follow-Up 1)	2117.1 Titer

Secondary

ELISA (Mucosal IgA) GMT

Geometric Mean Titers (GMTs) based on mucosal RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '1' (i.e. 1/2 DL)

Time frame: within 82 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 16 (Follow-Up 1)	13.0 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Individual Peak (Main Study)	18.6 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 6 (Main Study)	13.1 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Individual Peak (Booster Substudy)	18.2 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 8 (Main Study)	13.5 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 58 (Booster Substudy)	15.0 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 2 (Main Study)	14.1 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 0 (Main Study)	12.0 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 56 (Booster Substudy)	15.6 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 60 (Booster Substudy)	16.4 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 30 (Follow-Up 2)	13.1 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 4 (Main Study)	13.6 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 68 (Booster Follow-Up 1)	16.9 Titer
Group 1 - Single Low Dose / Booster	ELISA (Mucosal IgA) GMT	Week 82 (Booster Follow-Up 2)	12.7 Titer
Group 2 - Two Low Doses	ELISA (Mucosal IgA) GMT	Week 16 (Follow-Up 1)	11.9 Titer
Group 2 - Two Low Doses	ELISA (Mucosal IgA) GMT	Week 0 (Main Study)	10.9 Titer
Group 2 - Two Low Doses	ELISA (Mucosal IgA) GMT	Week 2 (Main Study)	12.1 Titer
Group 2 - Two Low Doses	ELISA (Mucosal IgA) GMT	Week 4 (Main Study)	13.1 Titer
Group 2 - Two Low Doses	ELISA (Mucosal IgA) GMT	Week 6 (Main Study)	13.4 Titer
Group 2 - Two Low Doses	ELISA (Mucosal IgA) GMT	Week 8 (Main Study)	12.6 Titer
Group 2 - Two Low Doses	ELISA (Mucosal IgA) GMT	Individual Peak (Main Study)	18.0 Titer
Group 2 - Two Low Doses	ELISA (Mucosal IgA) GMT	Week 30 (Follow-Up 2)	12.1 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 6 (Main Study)	13.2 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 8 (Main Study)	13.1 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 68 (Booster Follow-Up 1)	13.3 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Individual Peak (Main Study)	20.5 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 4 (Main Study)	14.1 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 16 (Follow-Up 1)	13.2 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 82 (Booster Follow-Up 2)	8.4 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 30 (Follow-Up 2)	13.4 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 2 (Main Study)	15.7 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 56 (Booster Substudy)	11.9 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 58 (Booster Substudy)	14.6 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 60 (Booster Substudy)	13.8 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Individual Peak (Booster Substudy)	16.5 Titer
Group 3 - Single High Dose / Booster	ELISA (Mucosal IgA) GMT	Week 0 (Main Study)	11.9 Titer
Group 4 - Two High Doses	ELISA (Mucosal IgA) GMT	Week 30 (Follow-Up 2)	13.6 Titer
Group 4 - Two High Doses	ELISA (Mucosal IgA) GMT	Individual Peak (Main Study)	21.4 Titer
Group 4 - Two High Doses	ELISA (Mucosal IgA) GMT	Week 8 (Main Study)	14.6 Titer
Group 4 - Two High Doses	ELISA (Mucosal IgA) GMT	Week 4 (Main Study)	15.0 Titer
Group 4 - Two High Doses	ELISA (Mucosal IgA) GMT	Week 6 (Main Study)	15.1 Titer
Group 4 - Two High Doses	ELISA (Mucosal IgA) GMT	Week 0 (Main Study)	13.7 Titer
Group 4 - Two High Doses	ELISA (Mucosal IgA) GMT	Week 16 (Follow-Up 1)	13.0 Titer
Group 4 - Two High Doses	ELISA (Mucosal IgA) GMT	Week 2 (Main Study)	15.2 Titer
Group 5 - Placebo	ELISA (Mucosal IgA) GMT	Week 16 (Follow-Up 1)	11.7 Titer
Group 5 - Placebo	ELISA (Mucosal IgA) GMT	Week 0 (Main Study)	12.3 Titer
Group 5 - Placebo	ELISA (Mucosal IgA) GMT	Week 6 (Main Study)	12.4 Titer
Group 5 - Placebo	ELISA (Mucosal IgA) GMT	Week 8 (Main Study)	11.2 Titer
Group 5 - Placebo	ELISA (Mucosal IgA) GMT	Week 4 (Main Study)	12.2 Titer
Group 5 - Placebo	ELISA (Mucosal IgA) GMT	Week 30 (Follow-Up 2)	13.1 Titer
Group 5 - Placebo	ELISA (Mucosal IgA) GMT	Individual Peak (Main Study)	17.3 Titer
Group 5 - Placebo	ELISA (Mucosal IgA) GMT	Week 2 (Main Study)	12.0 Titer

Secondary

ELISPOT (IFN-g, Peptide Pool: F) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Time frame: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 0 (Main Study)	283.2 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 1 (Main Study)	683.3 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 2 (Main Study)	589.5 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 5 (Main Study)	420.1 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 6 (Main Study)	392.5 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 56 (Booster Substudy)	282.6 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 57 (Booster Substudy)	628.7 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 58 (Booster Substudy)	514.4 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 6 (Main Study)	348.9 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 2 (Main Study)	384.9 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 0 (Main Study)	141.3 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 1 (Main Study)	662.9 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 5 (Main Study)	353.4 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 1 (Main Study)	940.4 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 0 (Main Study)	142.6 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 56 (Booster Substudy)	378.8 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 58 (Booster Substudy)	539.7 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 6 (Main Study)	502.8 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 5 (Main Study)	496.4 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 57 (Booster Substudy)	566.2 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 2 (Main Study)	591.0 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 1 (Main Study)	810.2 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 2 (Main Study)	598.2 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 5 (Main Study)	608.6 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 6 (Main Study)	553.1 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 0 (Main Study)	245.8 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 1 (Main Study)	117.1 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 0 (Main Study)	138.9 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 6 (Main Study)	122.9 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 2 (Main Study)	144.3 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: F) GMSFU	Week 5 (Main Study)	140.9 Spot Forming Units / 10^6 PBMC

Secondary

ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Time frame: within 58 weeks

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 0 (Main Study)	124.2 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 1 (Main Study)	517.9 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 2 (Main Study)	369.3 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 5 (Main Study)	271.1 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 6 (Main Study)	216.8 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 56 (Booster Substudy)	126.5 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 57 (Booster Substudy)	413.6 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 58 (Booster Substudy)	384.4 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 6 (Main Study)	185.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 2 (Main Study)	190.5 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 0 (Main Study)	70.2 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 1 (Main Study)	370.9 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 5 (Main Study)	180.9 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 1 (Main Study)	564.7 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 0 (Main Study)	66.2 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 56 (Booster Substudy)	116.1 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 58 (Booster Substudy)	251.7 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 6 (Main Study)	226.6 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 5 (Main Study)	209.6 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 57 (Booster Substudy)	217.4 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 2 (Main Study)	290.0 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 1 (Main Study)	659.7 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 2 (Main Study)	432.7 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 5 (Main Study)	415.7 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 6 (Main Study)	373.6 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 0 (Main Study)	150.7 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 1 (Main Study)	68.2 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 0 (Main Study)	88.1 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 6 (Main Study)	70.4 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 2 (Main Study)	71.2 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU	Week 5 (Main Study)	68.9 Spot Forming Units / 10^6 PBMC

Secondary

ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Time frame: within 58 weeks

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 0 (Main Study)	111.3 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 1 (Main Study)	399.6 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 2 (Main Study)	247.9 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 5 (Main Study)	196.9 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 6 (Main Study)	177.8 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 56 (Booster Substudy)	87.8 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 57 (Booster Substudy)	300.6 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 58 (Booster Substudy)	246.7 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 6 (Main Study)	219.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 2 (Main Study)	141.4 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 0 (Main Study)	63.4 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 1 (Main Study)	306.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 5 (Main Study)	184.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 1 (Main Study)	305.6 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 0 (Main Study)	56.8 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 56 (Booster Substudy)	57.5 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 58 (Booster Substudy)	132.2 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 6 (Main Study)	128.1 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 5 (Main Study)	138.8 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 57 (Booster Substudy)	101.2 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 2 (Main Study)	181.2 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 1 (Main Study)	613.0 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 2 (Main Study)	371.5 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 5 (Main Study)	406.8 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 6 (Main Study)	359.7 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 0 (Main Study)	135.5 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 1 (Main Study)	65.6 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 0 (Main Study)	73.6 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 6 (Main Study)	77.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 2 (Main Study)	71.6 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU	Week 5 (Main Study)	86.6 Spot Forming Units / 10^6 PBMC

Secondary

ELISPOT (IFN-g, Peptide Pool: M2) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Time frame: within 58 weeks

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 0 (Main Study)	84.1 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 1 (Main Study)	353.2 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 2 (Main Study)	281.9 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 5 (Main Study)	185.9 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 6 (Main Study)	208.2 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 56 (Booster Substudy)	86.8 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 57 (Booster Substudy)	242.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 58 (Booster Substudy)	237.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 6 (Main Study)	161.1 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 2 (Main Study)	136.9 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 0 (Main Study)	41.2 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 1 (Main Study)	247.9 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 5 (Main Study)	140.5 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 1 (Main Study)	418.8 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 0 (Main Study)	54.9 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 56 (Booster Substudy)	56.3 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 58 (Booster Substudy)	216.5 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 6 (Main Study)	169.6 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 5 (Main Study)	208.8 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 57 (Booster Substudy)	181.3 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 2 (Main Study)	284.7 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 1 (Main Study)	352.5 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 2 (Main Study)	317.9 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 5 (Main Study)	345.5 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 6 (Main Study)	333.4 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 0 (Main Study)	86.6 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 1 (Main Study)	49.3 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 0 (Main Study)	60.5 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 6 (Main Study)	54.6 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 2 (Main Study)	42.4 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: M2) GMSFU	Week 5 (Main Study)	60.4 Spot Forming Units / 10^6 PBMC

Secondary

ELISPOT (IFN-g, Peptide Pool: N) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Time frame: within 58 weeks

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 0 (Main Study)	179.2 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 1 (Main Study)	652.1 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 2 (Main Study)	567.7 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 5 (Main Study)	452.8 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 6 (Main Study)	401.3 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 56 (Booster Substudy)	164.3 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 57 (Booster Substudy)	475.6 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 58 (Booster Substudy)	471.1 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 6 (Main Study)	401.8 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 2 (Main Study)	377.2 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 0 (Main Study)	97.1 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 1 (Main Study)	534.9 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 5 (Main Study)	407.7 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 1 (Main Study)	825.9 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 0 (Main Study)	85.1 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 56 (Booster Substudy)	166.2 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 58 (Booster Substudy)	436.6 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 6 (Main Study)	386.5 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 5 (Main Study)	399.7 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 57 (Booster Substudy)	385.4 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 2 (Main Study)	521.3 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 1 (Main Study)	624.2 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 2 (Main Study)	523.4 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 5 (Main Study)	513.4 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 6 (Main Study)	544.0 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 0 (Main Study)	169.4 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 1 (Main Study)	86.8 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 0 (Main Study)	82.7 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 6 (Main Study)	78.1 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 2 (Main Study)	86.5 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IFN-g, Peptide Pool: N) GMSFU	Week 5 (Main Study)	93.7 Spot Forming Units / 10^6 PBMC

Secondary

ELISPOT (IL-4, Peptide Pool: F) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Time frame: within 58 weeks

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 1 (Main Study)	33.5 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 2 (Main Study)	28.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 6 (Main Study)	26.6 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 56 (Booster Substudy)	26.7 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 57 (Booster Substudy)	34.7 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 58 (Booster Substudy)	27.4 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 2 (Main Study)	29.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 1 (Main Study)	29.2 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 1 (Main Study)	44.3 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 56 (Booster Substudy)	26.5 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 58 (Booster Substudy)	27.9 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 6 (Main Study)	30.6 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 5 (Main Study)	32.8 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 57 (Booster Substudy)	28.5 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 2 (Main Study)	34.1 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 1 (Main Study)	49.6 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 2 (Main Study)	34.8 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 5 (Main Study)	35.5 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 6 (Main Study)	29.1 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 1 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 2 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: F) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC

Secondary

ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Time frame: within 58 weeks

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 1 (Main Study)	32.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 2 (Main Study)	30.4 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 5 (Main Study)	26.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 57 (Booster Substudy)	40.4 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 58 (Booster Substudy)	33.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 2 (Main Study)	26.6 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 1 (Main Study)	27.7 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 5 (Main Study)	26.5 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 1 (Main Study)	33.7 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 58 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 6 (Main Study)	27.3 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 5 (Main Study)	26.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 57 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 2 (Main Study)	31.5 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 1 (Main Study)	48.2 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 2 (Main Study)	31.1 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 5 (Main Study)	33.4 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 6 (Main Study)	31.4 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 1 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 2 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC

Secondary

ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Time frame: within 58 weeks

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 1 (Main Study)	30.1 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 2 (Main Study)	28.1 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 5 (Main Study)	26.4 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 56 (Booster Substudy)	26.2 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 57 (Booster Substudy)	38.1 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 58 (Booster Substudy)	29.8 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 2 (Main Study)	27.9 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 1 (Main Study)	27.4 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 1 (Main Study)	34.2 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 58 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 6 (Main Study)	27.2 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 5 (Main Study)	26.9 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 57 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 2 (Main Study)	29.1 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 1 (Main Study)	43.4 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 2 (Main Study)	29.5 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 5 (Main Study)	32.8 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 6 (Main Study)	31.3 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 1 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 2 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC

Secondary

ELISPOT (IL-4, Peptide Pool: M2) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Time frame: within 58 weeks

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 1 (Main Study)	28.1 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 2 (Main Study)	28.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 6 (Main Study)	27.4 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 57 (Booster Substudy)	28.9 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 58 (Booster Substudy)	26.6 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 2 (Main Study)	26.7 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 1 (Main Study)	25.9 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 5 (Main Study)	26.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 1 (Main Study)	39.1 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 58 (Booster Substudy)	26.7 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 6 (Main Study)	28.1 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 5 (Main Study)	30.6 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 57 (Booster Substudy)	28.1 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 2 (Main Study)	30.8 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 1 (Main Study)	28.8 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 2 (Main Study)	27.0 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 5 (Main Study)	30.0 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 6 (Main Study)	29.5 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 1 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 2 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: M2) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC

Secondary

ELISPOT (IL-4, Peptide Pool: N) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Time frame: within 58 weeks

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 1 (Main Study)	28.7 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 2 (Main Study)	26.5 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 57 (Booster Substudy)	28.9 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 58 (Booster Substudy)	27.3 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 6 (Main Study)	31.3 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 2 (Main Study)	29.1 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 1 (Main Study)	32.9 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 5 (Main Study)	30.1 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 1 (Main Study)	41.4 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 58 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 6 (Main Study)	27.3 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 57 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 2 (Main Study)	27.9 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 1 (Main Study)	35.3 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 2 (Main Study)	30.2 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 5 (Main Study)	28.0 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 6 (Main Study)	28.1 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 1 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 6 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 2 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	ELISPOT (IL-4, Peptide Pool: N) GMSFU	Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC

Secondary

Grade ≥ 3 Serious Adverse Events

Number of participants reporting Serious Adverse Events with intensity ≥ Grade 3 per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts \[retrospectively collected in booster substudy\], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.

Time frame: within 108 weeks (Main Study + Booster Substudy)

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Serious Adverse Events	Vaccination Period 1, Main Study	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Serious Adverse Events	Vaccination Period 2, Main Study	1 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Serious Adverse Events	Follow-Up, Main Study	1 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Serious Adverse Events	Between Study Parts	1 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Serious Adverse Events	Booster Vaccination Period, Booster Substudy	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Serious Adverse Events	Follow-Up, Booster Substudy	1 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Serious Adverse Events	Vaccination Period 2, Main Study	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Serious Adverse Events	Follow-Up, Main Study	3 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Serious Adverse Events	Vaccination Period 1, Main Study	1 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Serious Adverse Events	Follow-Up, Main Study	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Serious Adverse Events	Between Study Parts	1 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Serious Adverse Events	Vaccination Period 2, Main Study	1 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Serious Adverse Events	Follow-Up, Booster Substudy	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Serious Adverse Events	Booster Vaccination Period, Booster Substudy	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Serious Adverse Events	Vaccination Period 1, Main Study	1 Participants
Group 4 - Two High Doses	Grade ≥ 3 Serious Adverse Events	Vaccination Period 2, Main Study	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Serious Adverse Events	Vaccination Period 1, Main Study	1 Participants
Group 4 - Two High Doses	Grade ≥ 3 Serious Adverse Events	Follow-Up, Main Study	0 Participants
Group 5 - Placebo	Grade ≥ 3 Serious Adverse Events	Vaccination Period 1, Main Study	0 Participants
Group 5 - Placebo	Grade ≥ 3 Serious Adverse Events	Vaccination Period 2, Main Study	1 Participants
Group 5 - Placebo	Grade ≥ 3 Serious Adverse Events	Follow-Up, Main Study	2 Participants

Secondary

Grade ≥ 3 Solicited General Adverse Events

Incidence of systemic reactions (solicited via diary cards) with intensity ≥ Grade 3 after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Time frame: within 8 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Vaccination Period 2	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Booster Vaccination Period	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Booster Vaccination Period	2 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Booster Vaccination Period	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Booster Vaccination Period	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Vaccination Period 2	1 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Vaccination Period 2	1 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Vaccination Period 2	2 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Booster Vaccination Period	1 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Booster Vaccination Period	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Vaccination Period 2	3 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Vaccination Period 2	1 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Vaccination Period 1	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Vaccination Period 1	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Vaccination Period 1	1 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Vaccination Period 2	1 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Vaccination Period 2	1 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Vaccination Period 1	1 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Vaccination Period 1	1 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Vaccination Period 1	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Booster Vaccination Period	1 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Vaccination Period 1	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Vaccination Period 2	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Booster Vaccination Period	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Vaccination Period 1	2 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Vaccination Period 2	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Booster Vaccination Period	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Vaccination Period 1	4 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Vaccination Period 2	1 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Booster Vaccination Period	2 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Vaccination Period 1	3 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Vaccination Period 2	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Booster Vaccination Period	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Vaccination Period 1	1 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Vaccination Period 2	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Booster Vaccination Period	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Vaccination Period 1	4 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Vaccination Period 2	1 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Vaccination Period 2	1 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Vaccination Period 1	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Vaccination Period 1	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Vaccination Period 1	3 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Vaccination Period 2	2 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Vaccination Period 2	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Vaccination Period 2	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Vaccination Period 1	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Vaccination Period 1	2 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Vaccination Period 1	1 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Vaccination Period 2	1 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Vaccination Period 1	1 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Vaccination Period 1	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fever - Vaccination Period 1	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Vaccination Period 1	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Myalgia - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Headache - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Vaccination Period 1	1 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Vaccination Period 1	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Nausea - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Chills - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited General Adverse Events	Grade ≥ 3 Fatigue - Vaccination Period 2	0 Participants

Secondary

Grade ≥ 3 Solicited Local Adverse Events

Incidence of injection site reactions (solicited via diary cards) with intensity ≥ Grade 3 after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Time frame: within 8 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Booster Vaccination Period	2 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Booster Vaccination Period	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Booster Vaccination Period	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Vaccination Period 2	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Vaccination Period 2	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Booster Vaccination Period	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Vaccination Period 2	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Vaccination Period 1	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Vaccination Period 2	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Booster Vaccination Period	0 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Vaccination Period 1	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Vaccination Period 1	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Vaccination Period 1	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Vaccination Period 1	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Vaccination Period 1	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Vaccination Period 2	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Vaccination Period 1	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Vaccination Period 1	2 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Vaccination Period 2	1 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Booster Vaccination Period	4 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Vaccination Period 2	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Booster Vaccination Period	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Vaccination Period 1	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Vaccination Period 2	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Booster Vaccination Period	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Vaccination Period 1	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Vaccination Period 2	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Booster Vaccination Period	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Vaccination Period 1	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Vaccination Period 2	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Booster Vaccination Period	1 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Vaccination Period 2	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Vaccination Period 1	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Vaccination Period 1	7 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Vaccination Period 2	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Vaccination Period 2	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Vaccination Period 2	1 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Vaccination Period 1	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Vaccination Period 1	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Vaccination Period 2	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Vaccination Period 1	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Erythema - Vaccination Period 1	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Induration - Vaccination Period 1	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pruritis - Vaccination Period 1	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Vaccination Period 2	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Swelling - Vaccination Period 1	0 Participants
Group 5 - Placebo	Grade ≥ 3 Solicited Local Adverse Events	Grade ≥ 3 Pain - Vaccination Period 1	0 Participants

Secondary

Grade ≥ 3 Unsolicited Non-serious Adverse Events

Incidence of unsolicited non-serious adverse events with intensity ≥ Grade 3 by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.

Time frame: within 29 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Vaccination Period 1	1 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Vaccination Period 2	2 Participants
Group 1 - Single Low Dose / Booster	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Booster Vaccination Period	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Vaccination Period 1	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Booster Vaccination Period	0 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Vaccination Period 1	3 Participants
Group 3 - Single High Dose / Booster	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Vaccination Period 2	1 Participants
Group 4 - Two High Doses	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Vaccination Period 2	0 Participants
Group 4 - Two High Doses	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Vaccination Period 1	0 Participants
Group 5 - Placebo	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Vaccination Period 2	2 Participants
Group 5 - Placebo	Grade ≥ 3 Unsolicited Non-serious Adverse Events	Vaccination Period 1	0 Participants

Secondary

Memory B Cells (IgG) GMSFU

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Immunoglobulin G (IgG)-producing memory B cells. Negative results (i.e. results below 0.01) are included with a value of '0.005'

Time frame: within 82 weeks

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	Memory B Cells (IgG) GMSFU	Week 56 (Booster Substudy)	0.127 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	Memory B Cells (IgG) GMSFU	Week 82 (Booster Follow-Up 2)	0.103 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	Memory B Cells (IgG) GMSFU	Week 68 (Booster Follow-Up 1)	0.104 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	Memory B Cells (IgG) GMSFU	Week 16 (Follow-Up 1)	0.171 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	Memory B Cells (IgG) GMSFU	Week 30 (Follow-Up 2)	0.148 Spot Forming Units / 10^6 PBMC
Group 1 - Single Low Dose / Booster	Memory B Cells (IgG) GMSFU	Week 0 (Main Study)	0.091 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	Memory B Cells (IgG) GMSFU	Week 30 (Follow-Up 2)	0.068 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	Memory B Cells (IgG) GMSFU	Week 0 (Main Study)	0.083 Spot Forming Units / 10^6 PBMC
Group 2 - Two Low Doses	Memory B Cells (IgG) GMSFU	Week 16 (Follow-Up 1)	0.099 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	Memory B Cells (IgG) GMSFU	Week 82 (Booster Follow-Up 2)	0.167 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	Memory B Cells (IgG) GMSFU	Week 0 (Main Study)	0.068 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	Memory B Cells (IgG) GMSFU	Week 16 (Follow-Up 1)	0.173 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	Memory B Cells (IgG) GMSFU	Week 30 (Follow-Up 2)	0.123 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	Memory B Cells (IgG) GMSFU	Week 56 (Booster Substudy)	0.138 Spot Forming Units / 10^6 PBMC
Group 3 - Single High Dose / Booster	Memory B Cells (IgG) GMSFU	Week 68 (Booster Follow-Up 1)	0.231 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	Memory B Cells (IgG) GMSFU	Week 16 (Follow-Up 1)	0.210 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	Memory B Cells (IgG) GMSFU	Week 0 (Main Study)	0.129 Spot Forming Units / 10^6 PBMC
Group 4 - Two High Doses	Memory B Cells (IgG) GMSFU	Week 30 (Follow-Up 2)	0.100 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	Memory B Cells (IgG) GMSFU	Week 30 (Follow-Up 2)	0.079 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	Memory B Cells (IgG) GMSFU	Week 16 (Follow-Up 1)	0.130 Spot Forming Units / 10^6 PBMC
Group 5 - Placebo	Memory B Cells (IgG) GMSFU	Week 0 (Main Study)	0.117 Spot Forming Units / 10^6 PBMC

Secondary

Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)

Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Time frame: within 58 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 5 (Main Study)	23.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 6 (Main Study)	41.2 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 58 (Booster Substudy)	40.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 2 (Main Study)	61.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 57 (Booster Substudy)	53.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 1 (Main Study)	57.1 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 5 (Main Study)	63.2 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 6 (Main Study)	61.1 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 2 (Main Study)	70.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 1 (Main Study)	95.2 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 58 (Booster Substudy)	14.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 1 (Main Study)	100.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 2 (Main Study)	95.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 5 (Main Study)	65.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 6 (Main Study)	68.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 57 (Booster Substudy)	21.4 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 5 (Main Study)	56.5 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 6 (Main Study)	63.6 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 2 (Main Study)	56.5 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 1 (Main Study)	73.9 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 5 (Main Study)	20.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 1 (Main Study)	8.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 2 (Main Study)	19.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)	Week 6 (Main Study)	10.0 percentage of subjects

Secondary

Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))

Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Time frame: within 58 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 5 (Main Study)	38.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 6 (Main Study)	58.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 58 (Booster Substudy)	60.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 2 (Main Study)	72.2 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 57 (Booster Substudy)	60.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 1 (Main Study)	81.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 5 (Main Study)	68.4 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 6 (Main Study)	66.7 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 2 (Main Study)	65.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 1 (Main Study)	81.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 58 (Booster Substudy)	57.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 1 (Main Study)	95.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 2 (Main Study)	85.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 5 (Main Study)	70.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 6 (Main Study)	68.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 57 (Booster Substudy)	50.0 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 5 (Main Study)	65.2 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 6 (Main Study)	63.6 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 2 (Main Study)	69.6 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 1 (Main Study)	82.6 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 5 (Main Study)	5.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 1 (Main Study)	8.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 2 (Main Study)	9.5 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))	Week 6 (Main Study)	5.0 percentage of subjects

Secondary

Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))

Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Time frame: within 58 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 5 (Main Study)	42.9 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 6 (Main Study)	35.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 58 (Booster Substudy)	60.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 2 (Main Study)	55.6 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 57 (Booster Substudy)	60.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 1 (Main Study)	71.4 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 5 (Main Study)	63.2 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 6 (Main Study)	61.1 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 2 (Main Study)	55.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 1 (Main Study)	76.2 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 58 (Booster Substudy)	42.9 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 1 (Main Study)	85.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 2 (Main Study)	70.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 5 (Main Study)	60.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 6 (Main Study)	42.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 57 (Booster Substudy)	57.1 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 5 (Main Study)	65.2 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 6 (Main Study)	68.2 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 2 (Main Study)	60.9 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 1 (Main Study)	78.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 5 (Main Study)	10.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 1 (Main Study)	12.5 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 2 (Main Study)	14.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))	Week 6 (Main Study)	5.0 percentage of subjects

Secondary

Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)

Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Time frame: within 58 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 5 (Main Study)	57.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 6 (Main Study)	58.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 58 (Booster Substudy)	60.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 2 (Main Study)	72.2 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 57 (Booster Substudy)	66.7 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 1 (Main Study)	81.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 5 (Main Study)	78.9 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 6 (Main Study)	66.7 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 2 (Main Study)	65.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 1 (Main Study)	71.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 58 (Booster Substudy)	76.9 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 1 (Main Study)	95.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 2 (Main Study)	90.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 5 (Main Study)	85.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 6 (Main Study)	68.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 57 (Booster Substudy)	76.9 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 5 (Main Study)	78.3 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 6 (Main Study)	72.7 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 2 (Main Study)	65.2 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 1 (Main Study)	87.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 5 (Main Study)	15.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 1 (Main Study)	8.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 2 (Main Study)	9.5 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)	Week 6 (Main Study)	0.0 percentage of subjects

Secondary

Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)

Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Time frame: within 58 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 5 (Main Study)	57.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 6 (Main Study)	64.7 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 58 (Booster Substudy)	80.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 2 (Main Study)	72.2 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 57 (Booster Substudy)	60.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 1 (Main Study)	76.2 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 5 (Main Study)	84.2 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 6 (Main Study)	72.2 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 2 (Main Study)	75.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 1 (Main Study)	85.7 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 58 (Booster Substudy)	64.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 1 (Main Study)	100.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 2 (Main Study)	95.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 5 (Main Study)	95.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 6 (Main Study)	73.7 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 57 (Booster Substudy)	78.6 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 5 (Main Study)	65.2 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 6 (Main Study)	72.7 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 2 (Main Study)	60.9 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 1 (Main Study)	78.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 5 (Main Study)	20.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 1 (Main Study)	16.7 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 2 (Main Study)	19.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)	Week 6 (Main Study)	15.0 percentage of subjects

Secondary

Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)

Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Time frame: within 58 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 5 (Main Study)	0.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 6 (Main Study)	5.9 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 58 (Booster Substudy)	6.7 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 2 (Main Study)	11.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 57 (Booster Substudy)	20.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 1 (Main Study)	19.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 5 (Main Study)	0.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 6 (Main Study)	0.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 2 (Main Study)	15.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 1 (Main Study)	14.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 58 (Booster Substudy)	7.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 1 (Main Study)	30.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 2 (Main Study)	20.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 5 (Main Study)	20.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 6 (Main Study)	15.8 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 57 (Booster Substudy)	7.1 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 5 (Main Study)	34.8 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 6 (Main Study)	13.6 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 2 (Main Study)	21.7 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 1 (Main Study)	47.8 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 5 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 1 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 2 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)	Week 6 (Main Study)	0.0 percentage of subjects

Secondary

Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))

Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Time frame: within 58 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 5 (Main Study)	4.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 6 (Main Study)	0.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 58 (Booster Substudy)	20.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 2 (Main Study)	16.7 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 57 (Booster Substudy)	20.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 1 (Main Study)	14.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 5 (Main Study)	5.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 6 (Main Study)	0.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 2 (Main Study)	5.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 1 (Main Study)	9.5 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 58 (Booster Substudy)	0.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 1 (Main Study)	15.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 2 (Main Study)	20.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 5 (Main Study)	5.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 6 (Main Study)	5.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 57 (Booster Substudy)	0.0 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 5 (Main Study)	17.4 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 6 (Main Study)	18.2 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 2 (Main Study)	17.4 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 1 (Main Study)	43.5 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 5 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 1 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 2 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))	Week 6 (Main Study)	0.0 percentage of subjects

Secondary

Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))

Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Time frame: within 58 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 5 (Main Study)	4.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 6 (Main Study)	0.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 58 (Booster Substudy)	13.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 2 (Main Study)	5.6 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 57 (Booster Substudy)	20.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 1 (Main Study)	9.5 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 5 (Main Study)	0.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 6 (Main Study)	0.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 2 (Main Study)	10.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 1 (Main Study)	9.5 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 58 (Booster Substudy)	0.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 1 (Main Study)	15.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 2 (Main Study)	10.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 5 (Main Study)	5.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 6 (Main Study)	5.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 57 (Booster Substudy)	0.0 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 5 (Main Study)	21.7 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 6 (Main Study)	18.2 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 2 (Main Study)	13.0 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 1 (Main Study)	39.1 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 5 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 1 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 2 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))	Week 6 (Main Study)	0.0 percentage of subjects

Secondary

Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)

Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Time frame: within 58 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 5 (Main Study)	0.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 6 (Main Study)	11.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 58 (Booster Substudy)	6.7 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 2 (Main Study)	11.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 57 (Booster Substudy)	6.7 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 1 (Main Study)	9.5 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 5 (Main Study)	5.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 6 (Main Study)	0.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 2 (Main Study)	5.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 1 (Main Study)	4.8 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 58 (Booster Substudy)	7.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 1 (Main Study)	25.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 2 (Main Study)	10.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 5 (Main Study)	15.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 6 (Main Study)	5.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 57 (Booster Substudy)	7.1 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 5 (Main Study)	13.0 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 6 (Main Study)	9.1 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 2 (Main Study)	8.7 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 1 (Main Study)	13.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 5 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 1 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 2 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)	Week 6 (Main Study)	0.0 percentage of subjects

Secondary

Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)

Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Time frame: within 58 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 5 (Main Study)	0.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 6 (Main Study)	0.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 58 (Booster Substudy)	6.7 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 2 (Main Study)	5.6 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 57 (Booster Substudy)	6.7 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 1 (Main Study)	9.5 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 5 (Main Study)	15.8 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 6 (Main Study)	16.7 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 2 (Main Study)	10.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 1 (Main Study)	23.8 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 58 (Booster Substudy)	0.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 1 (Main Study)	45.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 2 (Main Study)	10.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 5 (Main Study)	0.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 6 (Main Study)	10.5 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 57 (Booster Substudy)	0.0 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 5 (Main Study)	8.7 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 6 (Main Study)	9.1 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 2 (Main Study)	13.0 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 1 (Main Study)	21.7 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 5 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 1 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 2 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)	Week 6 (Main Study)	0.0 percentage of subjects

Secondary

Percentage of Participants With Response by IgA ELISA

Response rate based on RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (100) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

Time frame: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Individual Peak (Main Study)	53.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 6 (Main Study)	28.9 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 2 (Main Study)	50.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Individual Peak (Booster Substudy)	39.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 60 (Booster Substudy)	17.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 8 (Main Study)	24.7 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 108 (Booster Follow-Up 3)	2.4 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 58 (Booster Substudy)	39.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 4 (Main Study)	32.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 30 (Follow-Up 2)	9.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 16 (Follow-Up 1)	14.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 82 (Booster Follow-Up 2)	7.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 68 (Booster Follow-Up 1)	7.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgA ELISA	Individual Peak (Main Study)	69.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgA ELISA	Week 6 (Main Study)	46.4 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgA ELISA	Week 8 (Main Study)	37.6 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgA ELISA	Week 16 (Follow-Up 1)	14.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgA ELISA	Week 30 (Follow-Up 2)	22.9 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgA ELISA	Week 4 (Main Study)	36.9 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgA ELISA	Week 2 (Main Study)	51.7 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 108 (Booster Follow-Up 3)	0.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 2 (Main Study)	68.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 4 (Main Study)	48.7 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 6 (Main Study)	44.9 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 8 (Main Study)	36.7 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Individual Peak (Main Study)	72.5 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 16 (Follow-Up 1)	28.6 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 30 (Follow-Up 2)	27.6 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 58 (Booster Substudy)	44.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 60 (Booster Substudy)	24.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Individual Peak (Booster Substudy)	44.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 68 (Booster Follow-Up 1)	6.7 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgA ELISA	Week 82 (Booster Follow-Up 2)	2.2 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgA ELISA	Week 8 (Main Study)	51.7 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgA ELISA	Week 2 (Main Study)	70.0 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgA ELISA	Week 16 (Follow-Up 1)	22.5 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgA ELISA	Week 4 (Main Study)	52.2 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgA ELISA	Individual Peak (Main Study)	77.8 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgA ELISA	Week 6 (Main Study)	62.2 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgA ELISA	Week 30 (Follow-Up 2)	30.7 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgA ELISA	Week 4 (Main Study)	7.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgA ELISA	Week 30 (Follow-Up 2)	14.6 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgA ELISA	Week 2 (Main Study)	7.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgA ELISA	Week 6 (Main Study)	3.7 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgA ELISA	Individual Peak (Main Study)	14.6 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgA ELISA	Week 16 (Follow-Up 1)	8.6 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgA ELISA	Week 8 (Main Study)	4.9 percentage of subjects

Secondary

Percentage of Participants With Response by IgG ELISA

Response rate based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (63) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

Time frame: within 108 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Individual Peak (Booster Substudy)	24.4 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 68 (Booster Follow-Up 1)	9.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 2 (Main Study)	21.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 16 (Follow-Up 1)	29.9 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 30 (Follow-Up 2)	13.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 4 (Main Study)	24.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Individual Peak (Main Study)	42.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 8 (Main Study)	29.9 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 6 (Main Study)	28.9 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 58 (Booster Substudy)	22.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 108 (Booster Follow-Up 3)	0.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 60 (Booster Substudy)	19.5 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 82 (Booster Follow-Up 2)	4.9 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgG ELISA	Week 16 (Follow-Up 1)	44.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgG ELISA	Week 30 (Follow-Up 2)	14.5 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgG ELISA	Week 6 (Main Study)	39.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgG ELISA	Week 8 (Main Study)	40.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgG ELISA	Individual Peak (Main Study)	53.4 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgG ELISA	Week 2 (Main Study)	19.5 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by IgG ELISA	Week 4 (Main Study)	27.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 58 (Booster Substudy)	22.2 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 6 (Main Study)	55.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 8 (Main Study)	54.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Individual Peak (Main Study)	70.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 30 (Follow-Up 2)	28.9 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 16 (Follow-Up 1)	45.5 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 4 (Main Study)	60.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 2 (Main Study)	51.9 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Individual Peak (Booster Substudy)	28.9 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 68 (Booster Follow-Up 1)	13.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 60 (Booster Substudy)	17.8 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 82 (Booster Follow-Up 2)	4.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by IgG ELISA	Week 108 (Booster Follow-Up 3)	4.5 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgG ELISA	Week 6 (Main Study)	58.9 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgG ELISA	Week 4 (Main Study)	46.7 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgG ELISA	Week 30 (Follow-Up 2)	26.1 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgG ELISA	Week 2 (Main Study)	44.4 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgG ELISA	Individual Peak (Main Study)	71.1 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgG ELISA	Week 8 (Main Study)	59.6 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by IgG ELISA	Week 16 (Follow-Up 1)	51.7 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgG ELISA	Week 8 (Main Study)	1.2 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgG ELISA	Week 16 (Follow-Up 1)	7.4 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgG ELISA	Week 4 (Main Study)	2.4 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgG ELISA	Week 30 (Follow-Up 2)	7.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgG ELISA	Week 6 (Main Study)	2.5 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgG ELISA	Week 2 (Main Study)	0.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by IgG ELISA	Individual Peak (Main Study)	4.9 percentage of subjects

Secondary

Percentage of Participants With Response by Mucosal IgA ELISA

Response rate based on mucosal RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (2) for initially negative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

Time frame: within 82 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 30 (Follow-Up 2)	12.5 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Individual Peak (Main Study)	25.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Individual Peak (Booster Substudy)	14.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 6 (Main Study)	12.5 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 2 (Main Study)	12.2 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 60 (Booster Substudy)	12.2 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 58 (Booster Substudy)	12.2 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 8 (Main Study)	13.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 82 (Booster Follow-Up 2)	15.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 4 (Main Study)	14.9 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 16 (Follow-Up 1)	12.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 68 (Booster Follow-Up 1)	7.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Individual Peak (Main Study)	34.5 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 8 (Main Study)	16.5 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 16 (Follow-Up 1)	15.9 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 30 (Follow-Up 2)	12.5 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 4 (Main Study)	12.7 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 2 (Main Study)	14.5 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 6 (Main Study)	17.7 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 82 (Booster Follow-Up 2)	0.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 2 (Main Study)	22.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 4 (Main Study)	13.5 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 6 (Main Study)	17.6 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 8 (Main Study)	20.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Individual Peak (Main Study)	33.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 16 (Follow-Up 1)	18.7 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 30 (Follow-Up 2)	20.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 58 (Booster Substudy)	7.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 60 (Booster Substudy)	2.5 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Individual Peak (Booster Substudy)	9.5 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by Mucosal IgA ELISA	Week 68 (Booster Follow-Up 1)	9.5 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 8 (Main Study)	11.9 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 30 (Follow-Up 2)	10.7 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 4 (Main Study)	14.0 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 6 (Main Study)	16.5 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 2 (Main Study)	12.5 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Individual Peak (Main Study)	28.4 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by Mucosal IgA ELISA	Week 16 (Follow-Up 1)	11.9 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by Mucosal IgA ELISA	Week 8 (Main Study)	6.7 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by Mucosal IgA ELISA	Week 2 (Main Study)	5.1 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by Mucosal IgA ELISA	Individual Peak (Main Study)	17.9 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by Mucosal IgA ELISA	Week 30 (Follow-Up 2)	11.5 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by Mucosal IgA ELISA	Week 6 (Main Study)	8.1 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by Mucosal IgA ELISA	Week 16 (Follow-Up 1)	7.7 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by Mucosal IgA ELISA	Week 4 (Main Study)	10.4 percentage of subjects

Secondary

Percentage of Participants With Response by PRNT (Subtype A)

Response rate based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Response is defined as the appearance of antibody titers ≥ detection limit (20) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

Time frame: within 108 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Individual Peak (Main Study)	23.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 6 (Main Study)	9.2 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 2 (Main Study)	10.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Individual Peak (Booster Substudy)	22.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 60 (Booster Substudy)	19.5 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 8 (Main Study)	7.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 108 (Booster Follow-Up 3)	2.4 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 58 (Booster Substudy)	17.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 4 (Main Study)	13.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 30 (Follow-Up 2)	1.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 16 (Follow-Up 1)	9.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 82 (Booster Follow-Up 2)	22.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 68 (Booster Follow-Up 1)	2.4 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype A)	Individual Peak (Main Study)	25.0 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 6 (Main Study)	15.5 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 8 (Main Study)	10.6 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 16 (Follow-Up 1)	8.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 30 (Follow-Up 2)	7.2 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 4 (Main Study)	11.9 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 2 (Main Study)	9.2 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 108 (Booster Follow-Up 3)	4.5 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 2 (Main Study)	27.8 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 4 (Main Study)	25.6 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 6 (Main Study)	19.2 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 8 (Main Study)	15.2 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Individual Peak (Main Study)	41.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 16 (Follow-Up 1)	10.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 30 (Follow-Up 2)	3.9 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 58 (Booster Substudy)	4.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 60 (Booster Substudy)	11.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Individual Peak (Booster Substudy)	15.6 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 68 (Booster Follow-Up 1)	0.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype A)	Week 82 (Booster Follow-Up 2)	13.3 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 8 (Main Study)	14.6 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 2 (Main Study)	23.3 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 16 (Follow-Up 1)	10.1 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 4 (Main Study)	8.9 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype A)	Individual Peak (Main Study)	34.4 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 6 (Main Study)	15.6 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype A)	Week 30 (Follow-Up 2)	2.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype A)	Week 4 (Main Study)	1.2 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype A)	Week 30 (Follow-Up 2)	3.7 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype A)	Week 2 (Main Study)	3.7 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype A)	Week 6 (Main Study)	4.9 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype A)	Individual Peak (Main Study)	7.3 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype A)	Week 16 (Follow-Up 1)	4.9 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype A)	Week 8 (Main Study)	1.2 percentage of subjects

Secondary

Percentage of Participants With Response by PRNT (Subtype B)

Response rate based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Response is defined as the appearance of antibody titers ≥ detection limit (20) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

Time frame: within 108 weeks

Arm	Measure	Group	Value (NUMBER)
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Individual Peak (Main Study)	25.6 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 6 (Main Study)	10.5 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 2 (Main Study)	12.8 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Individual Peak (Booster Substudy)	39.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 60 (Booster Substudy)	17.1 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 8 (Main Study)	15.6 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 108 (Booster Follow-Up 3)	4.9 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 58 (Booster Substudy)	39.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 4 (Main Study)	9.3 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 30 (Follow-Up 2)	20.0 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 16 (Follow-Up 1)	11.7 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 82 (Booster Follow-Up 2)	19.5 percentage of subjects
Group 1 - Single Low Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 68 (Booster Follow-Up 1)	14.6 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype B)	Individual Peak (Main Study)	34.1 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 6 (Main Study)	21.4 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 8 (Main Study)	11.8 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 16 (Follow-Up 1)	20.2 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 30 (Follow-Up 2)	13.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 4 (Main Study)	14.3 percentage of subjects
Group 2 - Two Low Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 2 (Main Study)	18.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 108 (Booster Follow-Up 3)	9.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 2 (Main Study)	26.6 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 4 (Main Study)	29.5 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 6 (Main Study)	24.4 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 8 (Main Study)	26.6 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Individual Peak (Main Study)	45.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 16 (Follow-Up 1)	22.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 30 (Follow-Up 2)	21.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 58 (Booster Substudy)	33.3 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 60 (Booster Substudy)	20.0 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Individual Peak (Booster Substudy)	35.6 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 68 (Booster Follow-Up 1)	11.1 percentage of subjects
Group 3 - Single High Dose / Booster	Percentage of Participants With Response by PRNT (Subtype B)	Week 82 (Booster Follow-Up 2)	17.8 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 8 (Main Study)	14.6 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 2 (Main Study)	14.4 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 16 (Follow-Up 1)	13.5 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 4 (Main Study)	11.1 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype B)	Individual Peak (Main Study)	34.4 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 6 (Main Study)	21.1 percentage of subjects
Group 4 - Two High Doses	Percentage of Participants With Response by PRNT (Subtype B)	Week 30 (Follow-Up 2)	11.4 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype B)	Week 4 (Main Study)	2.4 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype B)	Week 30 (Follow-Up 2)	11.0 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype B)	Week 2 (Main Study)	2.4 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype B)	Week 6 (Main Study)	4.9 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype B)	Individual Peak (Main Study)	9.8 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype B)	Week 16 (Follow-Up 1)	7.4 percentage of subjects
Group 5 - Placebo	Percentage of Participants With Response by PRNT (Subtype B)	Week 8 (Main Study)	2.5 percentage of subjects

Secondary

PRNT (Subtype A) GMT

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

Time frame: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 6 (Main Study)	300.5 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 16 (Follow-Up 1)	288.7 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 108 (Booster Follow-Up 3)	296.2 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 58 (Booster Substudy)	351.9 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 56 (Booster Substudy)	285.6 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 8 (Main Study)	292.0 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Individual Peak (Main Study)	381.7 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 2 (Main Study)	316.7 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 82 (Booster Follow-Up 2)	405.8 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 68 (Booster Follow-Up 1)	287.9 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 4 (Main Study)	307.5 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 30 (Follow-Up 2)	244.0 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 0 (Main Study)	256.4 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Individual Peak (Booster Substudy)	424.3 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype A) GMT	Week 60 (Booster Substudy)	402.1 Titer
Group 2 - Two Low Doses	PRNT (Subtype A) GMT	Week 4 (Main Study)	258.2 Titer
Group 2 - Two Low Doses	PRNT (Subtype A) GMT	Individual Peak (Main Study)	334.8 Titer
Group 2 - Two Low Doses	PRNT (Subtype A) GMT	Week 2 (Main Study)	259.8 Titer
Group 2 - Two Low Doses	PRNT (Subtype A) GMT	Week 16 (Follow-Up 1)	261.3 Titer
Group 2 - Two Low Doses	PRNT (Subtype A) GMT	Week 0 (Main Study)	208.0 Titer
Group 2 - Two Low Doses	PRNT (Subtype A) GMT	Week 30 (Follow-Up 2)	205.4 Titer
Group 2 - Two Low Doses	PRNT (Subtype A) GMT	Week 6 (Main Study)	278.9 Titer
Group 2 - Two Low Doses	PRNT (Subtype A) GMT	Week 8 (Main Study)	263.9 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 108 (Booster Follow-Up 3)	258.1 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 0 (Main Study)	234.9 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 2 (Main Study)	356.9 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 4 (Main Study)	342.5 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 6 (Main Study)	311.9 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 8 (Main Study)	304.0 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Individual Peak (Main Study)	450.1 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 16 (Follow-Up 1)	275.5 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 30 (Follow-Up 2)	228.2 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 56 (Booster Substudy)	264.2 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 58 (Booster Substudy)	286.0 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 60 (Booster Substudy)	341.2 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Individual Peak (Booster Substudy)	358.6 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 68 (Booster Follow-Up 1)	235.9 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype A) GMT	Week 82 (Booster Follow-Up 2)	333.9 Titer
Group 4 - Two High Doses	PRNT (Subtype A) GMT	Week 30 (Follow-Up 2)	266.7 Titer
Group 4 - Two High Doses	PRNT (Subtype A) GMT	Week 6 (Main Study)	373.3 Titer
Group 4 - Two High Doses	PRNT (Subtype A) GMT	Week 2 (Main Study)	398.8 Titer
Group 4 - Two High Doses	PRNT (Subtype A) GMT	Individual Peak (Main Study)	483.7 Titer
Group 4 - Two High Doses	PRNT (Subtype A) GMT	Week 4 (Main Study)	347.7 Titer
Group 4 - Two High Doses	PRNT (Subtype A) GMT	Week 16 (Follow-Up 1)	336.5 Titer
Group 4 - Two High Doses	PRNT (Subtype A) GMT	Week 8 (Main Study)	370.9 Titer
Group 4 - Two High Doses	PRNT (Subtype A) GMT	Week 0 (Main Study)	276.4 Titer
Group 5 - Placebo	PRNT (Subtype A) GMT	Individual Peak (Main Study)	309.9 Titer
Group 5 - Placebo	PRNT (Subtype A) GMT	Week 30 (Follow-Up 2)	202.2 Titer
Group 5 - Placebo	PRNT (Subtype A) GMT	Week 6 (Main Study)	229.3 Titer
Group 5 - Placebo	PRNT (Subtype A) GMT	Week 2 (Main Study)	235.0 Titer
Group 5 - Placebo	PRNT (Subtype A) GMT	Week 8 (Main Study)	231.5 Titer
Group 5 - Placebo	PRNT (Subtype A) GMT	Week 0 (Main Study)	251.7 Titer
Group 5 - Placebo	PRNT (Subtype A) GMT	Week 4 (Main Study)	252.7 Titer
Group 5 - Placebo	PRNT (Subtype A) GMT	Week 16 (Follow-Up 1)	242.9 Titer

Secondary

PRNT (Subtype B) GMT

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

Time frame: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 108 (Booster Follow-Up 3)	599.7 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 0 (Main Study)	424.3 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 2 (Main Study)	517.7 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 4 (Main Study)	485.8 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 6 (Main Study)	506.1 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 8 (Main Study)	509.0 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Individual Peak (Main Study)	672.2 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 16 (Follow-Up 1)	577.8 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 30 (Follow-Up 2)	570.6 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 56 (Booster Substudy)	561.0 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 58 (Booster Substudy)	894.1 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 60 (Booster Substudy)	761.7 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Individual Peak (Booster Substudy)	992.5 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 68 (Booster Follow-Up 1)	632.2 Titer
Group 1 - Single Low Dose / Booster	PRNT (Subtype B) GMT	Week 82 (Booster Follow-Up 2)	759.0 Titer
Group 2 - Two Low Doses	PRNT (Subtype B) GMT	Week 6 (Main Study)	507.4 Titer
Group 2 - Two Low Doses	PRNT (Subtype B) GMT	Week 4 (Main Study)	458.8 Titer
Group 2 - Two Low Doses	PRNT (Subtype B) GMT	Week 16 (Follow-Up 1)	505.7 Titer
Group 2 - Two Low Doses	PRNT (Subtype B) GMT	Week 2 (Main Study)	464.5 Titer
Group 2 - Two Low Doses	PRNT (Subtype B) GMT	Individual Peak (Main Study)	639.7 Titer
Group 2 - Two Low Doses	PRNT (Subtype B) GMT	Week 8 (Main Study)	483.5 Titer
Group 2 - Two Low Doses	PRNT (Subtype B) GMT	Week 0 (Main Study)	364.9 Titer
Group 2 - Two Low Doses	PRNT (Subtype B) GMT	Week 30 (Follow-Up 2)	458.1 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 6 (Main Study)	615.1 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 56 (Booster Substudy)	584.5 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 60 (Booster Substudy)	804.2 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 16 (Follow-Up 1)	639.0 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 82 (Booster Follow-Up 2)	782.3 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 2 (Main Study)	688.6 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 108 (Booster Follow-Up 3)	669.4 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 68 (Booster Follow-Up 1)	686.7 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 4 (Main Study)	635.9 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 0 (Main Study)	426.9 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 58 (Booster Substudy)	954.8 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Individual Peak (Booster Substudy)	1031.2 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 8 (Main Study)	670.1 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Week 30 (Follow-Up 2)	606.1 Titer
Group 3 - Single High Dose / Booster	PRNT (Subtype B) GMT	Individual Peak (Main Study)	932.3 Titer
Group 4 - Two High Doses	PRNT (Subtype B) GMT	Week 4 (Main Study)	570.0 Titer
Group 4 - Two High Doses	PRNT (Subtype B) GMT	Week 6 (Main Study)	674.3 Titer
Group 4 - Two High Doses	PRNT (Subtype B) GMT	Week 8 (Main Study)	610.2 Titer
Group 4 - Two High Doses	PRNT (Subtype B) GMT	Individual Peak (Main Study)	858.0 Titer
Group 4 - Two High Doses	PRNT (Subtype B) GMT	Week 16 (Follow-Up 1)	635.6 Titer
Group 4 - Two High Doses	PRNT (Subtype B) GMT	Week 30 (Follow-Up 2)	583.2 Titer
Group 4 - Two High Doses	PRNT (Subtype B) GMT	Week 0 (Main Study)	498.6 Titer
Group 4 - Two High Doses	PRNT (Subtype B) GMT	Week 2 (Main Study)	638.2 Titer
Group 5 - Placebo	PRNT (Subtype B) GMT	Week 30 (Follow-Up 2)	518.1 Titer
Group 5 - Placebo	PRNT (Subtype B) GMT	Week 16 (Follow-Up 1)	515.6 Titer
Group 5 - Placebo	PRNT (Subtype B) GMT	Week 4 (Main Study)	431.5 Titer
Group 5 - Placebo	PRNT (Subtype B) GMT	Week 2 (Main Study)	441.4 Titer
Group 5 - Placebo	PRNT (Subtype B) GMT	Individual Peak (Main Study)	614.6 Titer
Group 5 - Placebo	PRNT (Subtype B) GMT	Week 8 (Main Study)	465.3 Titer
Group 5 - Placebo	PRNT (Subtype B) GMT	Week 6 (Main Study)	454.0 Titer
Group 5 - Placebo	PRNT (Subtype B) GMT	Week 0 (Main Study)	477.5 Titer

Secondary

Related Grade ≥ 3 Adverse Events

Number of participants reporting Adverse Events possibly, probably or definitely related to the trial vaccine with intensity ≥ Grade 3 per period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Pooled solicited (general only) and unsolicited AEs. Percentages based on number of subjects still in the study at the start of the respective period.

Time frame: within 29 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Related Grade ≥ 3 Adverse Events	Vaccination Period 1, Main Study	0 Participants
Group 1 - Single Low Dose / Booster	Related Grade ≥ 3 Adverse Events	Vaccination Period 2, Main Study	3 Participants
Group 1 - Single Low Dose / Booster	Related Grade ≥ 3 Adverse Events	Booster Vaccination Period, Booster Substudy	3 Participants
Group 2 - Two Low Doses	Related Grade ≥ 3 Adverse Events	Vaccination Period 2, Main Study	1 Participants
Group 2 - Two Low Doses	Related Grade ≥ 3 Adverse Events	Vaccination Period 1, Main Study	3 Participants
Group 3 - Single High Dose / Booster	Related Grade ≥ 3 Adverse Events	Booster Vaccination Period, Booster Substudy	2 Participants
Group 3 - Single High Dose / Booster	Related Grade ≥ 3 Adverse Events	Vaccination Period 1, Main Study	6 Participants
Group 3 - Single High Dose / Booster	Related Grade ≥ 3 Adverse Events	Vaccination Period 2, Main Study	1 Participants
Group 4 - Two High Doses	Related Grade ≥ 3 Adverse Events	Vaccination Period 2, Main Study	2 Participants
Group 4 - Two High Doses	Related Grade ≥ 3 Adverse Events	Vaccination Period 1, Main Study	6 Participants
Group 5 - Placebo	Related Grade ≥ 3 Adverse Events	Vaccination Period 2, Main Study	0 Participants
Group 5 - Placebo	Related Grade ≥ 3 Adverse Events	Vaccination Period 1, Main Study	0 Participants

Secondary

Related Serious Adverse Events

Number of participants reporting Serious Adverse Events possibly, probably or definitely related to the trial vaccine per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts \[retrospectively collected in booster substudy\], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.

Time frame: within 108 weeks (Main Study + Booster Substudy)

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Related Serious Adverse Events	Follow-Up, Main Study	0 Participants
Group 1 - Single Low Dose / Booster	Related Serious Adverse Events	Vaccination Period 2, Main Study	0 Participants
Group 1 - Single Low Dose / Booster	Related Serious Adverse Events	Vaccination Period 1, Main Study	0 Participants
Group 1 - Single Low Dose / Booster	Related Serious Adverse Events	Follow-Up, Booster Substudy	0 Participants
Group 1 - Single Low Dose / Booster	Related Serious Adverse Events	Between Study Parts	0 Participants
Group 1 - Single Low Dose / Booster	Related Serious Adverse Events	Booster Vaccination Period, Booster Substudy	0 Participants
Group 2 - Two Low Doses	Related Serious Adverse Events	Vaccination Period 2, Main Study	0 Participants
Group 2 - Two Low Doses	Related Serious Adverse Events	Vaccination Period 1, Main Study	0 Participants
Group 2 - Two Low Doses	Related Serious Adverse Events	Booster Vaccination Period, Booster Substudy	0 Participants
Group 2 - Two Low Doses	Related Serious Adverse Events	Follow-Up, Booster Substudy	0 Participants
Group 2 - Two Low Doses	Related Serious Adverse Events	Follow-Up, Main Study	0 Participants
Group 3 - Single High Dose / Booster	Related Serious Adverse Events	Between Study Parts	0 Participants
Group 3 - Single High Dose / Booster	Related Serious Adverse Events	Booster Vaccination Period, Booster Substudy	0 Participants
Group 3 - Single High Dose / Booster	Related Serious Adverse Events	Follow-Up, Booster Substudy	0 Participants
Group 3 - Single High Dose / Booster	Related Serious Adverse Events	Vaccination Period 2, Main Study	0 Participants
Group 3 - Single High Dose / Booster	Related Serious Adverse Events	Vaccination Period 1, Main Study	0 Participants
Group 3 - Single High Dose / Booster	Related Serious Adverse Events	Follow-Up, Main Study	0 Participants
Group 4 - Two High Doses	Related Serious Adverse Events	Follow-Up, Main Study	0 Participants
Group 4 - Two High Doses	Related Serious Adverse Events	Vaccination Period 1, Main Study	0 Participants
Group 4 - Two High Doses	Related Serious Adverse Events	Vaccination Period 2, Main Study	0 Participants
Group 4 - Two High Doses	Related Serious Adverse Events	Booster Vaccination Period, Booster Substudy	0 Participants
Group 4 - Two High Doses	Related Serious Adverse Events	Follow-Up, Booster Substudy	0 Participants
Group 5 - Placebo	Related Serious Adverse Events	Follow-Up, Main Study	0 Participants
Group 5 - Placebo	Related Serious Adverse Events	Vaccination Period 2, Main Study	0 Participants
Group 5 - Placebo	Related Serious Adverse Events	Vaccination Period 1, Main Study	0 Participants
Group 5 - Placebo	Related Serious Adverse Events	Follow-Up, Booster Substudy	0 Participants
Group 5 - Placebo	Related Serious Adverse Events	Booster Vaccination Period, Booster Substudy	0 Participants

Secondary

Related Solicited General Adverse Events

Incidence of systemic reactions (solicited via diary cards) possibly, probably or definitely related to the trial vaccine after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Time frame: within 8 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Chills - Vaccination Period 1	4 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Fever - Vaccination Period 2	0 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Nausea - Booster Vaccination Period	1 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Nausea - Vaccination Period 1	1 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Headache - Booster Vaccination Period	7 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Fever - Booster Vaccination Period	0 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Myalgia - Vaccination Period 1	9 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Chills - Booster Vaccination Period	3 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Chills - Vaccination Period 2	3 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Nausea - Vaccination Period 2	6 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Fever - Vaccination Period 1	2 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Myalgia - Vaccination Period 2	5 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Headache - Vaccination Period 1	4 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Myalgia - Booster Vaccination Period	10 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Fatigue - Booster Vaccination Period	4 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Fatigue - Vaccination Period 2	8 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Fatigue - Vaccination Period 1	7 Participants
Group 1 - Single Low Dose / Booster	Related Solicited General Adverse Events	Related Headache - Vaccination Period 2	5 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Fatigue - Vaccination Period 1	12 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Fatigue - Vaccination Period 2	9 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Chills - Vaccination Period 1	4 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Chills - Vaccination Period 2	2 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Headache - Vaccination Period 1	14 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Myalgia - Vaccination Period 2	12 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Headache - Vaccination Period 2	12 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Nausea - Vaccination Period 2	2 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Fever - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Myalgia - Vaccination Period 1	18 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Fever - Vaccination Period 1	4 Participants
Group 2 - Two Low Doses	Related Solicited General Adverse Events	Related Nausea - Vaccination Period 1	5 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Fatigue - Booster Vaccination Period	15 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Fever - Vaccination Period 1	7 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Fever - Vaccination Period 2	2 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Fever - Booster Vaccination Period	2 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Headache - Vaccination Period 1	15 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Headache - Vaccination Period 2	4 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Headache - Booster Vaccination Period	12 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Myalgia - Vaccination Period 1	29 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Myalgia - Vaccination Period 2	3 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Myalgia - Booster Vaccination Period	23 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Chills - Vaccination Period 1	8 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Chills - Vaccination Period 2	5 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Chills - Booster Vaccination Period	4 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Nausea - Vaccination Period 1	4 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Nausea - Vaccination Period 2	2 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Nausea - Booster Vaccination Period	3 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Fatigue - Vaccination Period 1	18 Participants
Group 3 - Single High Dose / Booster	Related Solicited General Adverse Events	Related Fatigue - Vaccination Period 2	4 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Myalgia - Vaccination Period 2	18 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Fever - Vaccination Period 1	3 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Nausea - Vaccination Period 1	5 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Myalgia - Vaccination Period 1	29 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Fatigue - Vaccination Period 2	14 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Nausea - Vaccination Period 2	5 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Headache - Vaccination Period 2	12 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Headache - Vaccination Period 1	17 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Fatigue - Vaccination Period 1	23 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Chills - Vaccination Period 1	11 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Chills - Vaccination Period 2	8 Participants
Group 4 - Two High Doses	Related Solicited General Adverse Events	Related Fever - Vaccination Period 2	0 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Headache - Vaccination Period 1	7 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Myalgia - Vaccination Period 1	6 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Fever - Vaccination Period 2	0 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Fever - Vaccination Period 1	1 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Nausea - Vaccination Period 1	3 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Myalgia - Vaccination Period 2	6 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Headache - Vaccination Period 2	6 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Fatigue - Vaccination Period 1	3 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Chills - Vaccination Period 1	3 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Nausea - Vaccination Period 2	1 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Chills - Vaccination Period 2	4 Participants
Group 5 - Placebo	Related Solicited General Adverse Events	Related Fatigue - Vaccination Period 2	8 Participants

Secondary

Related Unsolicited Non-serious Adverse Events

Incidence of unsolicited non-serious adverse events possibly, probably or definitely related to the trial vaccine by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.

Time frame: within 29 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Related Unsolicited Non-serious Adverse Events	Vaccination Period 1	4 Participants
Group 1 - Single Low Dose / Booster	Related Unsolicited Non-serious Adverse Events	Vaccination Period 2	4 Participants
Group 1 - Single Low Dose / Booster	Related Unsolicited Non-serious Adverse Events	Booster Vaccination Period	0 Participants
Group 2 - Two Low Doses	Related Unsolicited Non-serious Adverse Events	Vaccination Period 2	2 Participants
Group 2 - Two Low Doses	Related Unsolicited Non-serious Adverse Events	Vaccination Period 1	6 Participants
Group 3 - Single High Dose / Booster	Related Unsolicited Non-serious Adverse Events	Booster Vaccination Period	3 Participants
Group 3 - Single High Dose / Booster	Related Unsolicited Non-serious Adverse Events	Vaccination Period 1	9 Participants
Group 3 - Single High Dose / Booster	Related Unsolicited Non-serious Adverse Events	Vaccination Period 2	5 Participants
Group 4 - Two High Doses	Related Unsolicited Non-serious Adverse Events	Vaccination Period 2	6 Participants
Group 4 - Two High Doses	Related Unsolicited Non-serious Adverse Events	Vaccination Period 1	9 Participants
Group 5 - Placebo	Related Unsolicited Non-serious Adverse Events	Vaccination Period 2	9 Participants
Group 5 - Placebo	Related Unsolicited Non-serious Adverse Events	Vaccination Period 1	4 Participants

Secondary

Serious Adverse Events

Number of participants reporting Serious Adverse Events per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts \[retrospectively collected in booster substudy\], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.

Time frame: within 108 weeks (Main Study + Booster Substudy)

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Serious Adverse Events	Follow-Up, Main Study	1 Participants
Group 1 - Single Low Dose / Booster	Serious Adverse Events	Follow-Up, Booster Substudy	1 Participants
Group 1 - Single Low Dose / Booster	Serious Adverse Events	Vaccination Period 2, Main Study	1 Participants
Group 1 - Single Low Dose / Booster	Serious Adverse Events	Between Study Parts	1 Participants
Group 1 - Single Low Dose / Booster	Serious Adverse Events	Vaccination Period 1, Main Study	0 Participants
Group 1 - Single Low Dose / Booster	Serious Adverse Events	Booster Vaccination Period, Booster Substudy	0 Participants
Group 2 - Two Low Doses	Serious Adverse Events	Vaccination Period 1, Main Study	1 Participants
Group 2 - Two Low Doses	Serious Adverse Events	Vaccination Period 2, Main Study	0 Participants
Group 2 - Two Low Doses	Serious Adverse Events	Follow-Up, Main Study	3 Participants
Group 3 - Single High Dose / Booster	Serious Adverse Events	Follow-Up, Booster Substudy	0 Participants
Group 3 - Single High Dose / Booster	Serious Adverse Events	Follow-Up, Main Study	0 Participants
Group 3 - Single High Dose / Booster	Serious Adverse Events	Vaccination Period 1, Main Study	2 Participants
Group 3 - Single High Dose / Booster	Serious Adverse Events	Vaccination Period 2, Main Study	1 Participants
Group 3 - Single High Dose / Booster	Serious Adverse Events	Between Study Parts	1 Participants
Group 3 - Single High Dose / Booster	Serious Adverse Events	Booster Vaccination Period, Booster Substudy	0 Participants
Group 4 - Two High Doses	Serious Adverse Events	Vaccination Period 2, Main Study	0 Participants
Group 4 - Two High Doses	Serious Adverse Events	Vaccination Period 1, Main Study	1 Participants
Group 4 - Two High Doses	Serious Adverse Events	Follow-Up, Main Study	1 Participants
Group 5 - Placebo	Serious Adverse Events	Vaccination Period 2, Main Study	2 Participants
Group 5 - Placebo	Serious Adverse Events	Vaccination Period 1, Main Study	0 Participants
Group 5 - Placebo	Serious Adverse Events	Follow-Up, Main Study	3 Participants

Secondary

Solicited General Adverse Events

Incidence of systemic reactions (solicited via diary cards) after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Time frame: within 8 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Fever - Vaccination Period 2	0 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Nausea - Booster Vaccination Period	1 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Chills - Vaccination Period 2	3 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Nausea - Vaccination Period 1	2 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Fever - Vaccination Period 1	2 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Fatigue - Booster Vaccination Period	4 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Myalgia - Vaccination Period 1	13 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Headache - Vaccination Period 1	4 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Fatigue - Vaccination Period 2	8 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Myalgia - Vaccination Period 2	5 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Headache - Booster Vaccination Period	9 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Myalgia - Booster Vaccination Period	10 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Fever - Booster Vaccination Period	0 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Chills - Vaccination Period 1	5 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Fatigue - Vaccination Period 1	7 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Nausea - Vaccination Period 2	7 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Chills - Booster Vaccination Period	3 Participants
Group 1 - Single Low Dose / Booster	Solicited General Adverse Events	Headache - Vaccination Period 2	7 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Chills - Vaccination Period 2	2 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Fever - Vaccination Period 1	4 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Nausea - Vaccination Period 2	3 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Myalgia - Vaccination Period 2	14 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Myalgia - Vaccination Period 1	19 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Headache - Vaccination Period 1	16 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Fatigue - Vaccination Period 2	9 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Nausea - Vaccination Period 1	6 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Headache - Vaccination Period 2	14 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Fever - Vaccination Period 2	0 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Chills - Vaccination Period 1	4 Participants
Group 2 - Two Low Doses	Solicited General Adverse Events	Fatigue - Vaccination Period 1	15 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Fatigue - Vaccination Period 1	22 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Headache - Booster Vaccination Period	13 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Fever - Booster Vaccination Period	3 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Headache - Vaccination Period 1	21 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Headache - Vaccination Period 2	8 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Myalgia - Vaccination Period 1	37 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Myalgia - Vaccination Period 2	5 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Myalgia - Booster Vaccination Period	24 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Chills - Vaccination Period 1	10 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Chills - Vaccination Period 2	5 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Chills - Booster Vaccination Period	4 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Nausea - Vaccination Period 1	4 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Nausea - Vaccination Period 2	2 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Nausea - Booster Vaccination Period	3 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Fatigue - Vaccination Period 2	4 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Fatigue - Booster Vaccination Period	16 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Fever - Vaccination Period 1	8 Participants
Group 3 - Single High Dose / Booster	Solicited General Adverse Events	Fever - Vaccination Period 2	2 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Fatigue - Vaccination Period 1	26 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Chills - Vaccination Period 1	11 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Myalgia - Vaccination Period 2	21 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Headache - Vaccination Period 2	16 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Myalgia - Vaccination Period 1	34 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Fever - Vaccination Period 2	0 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Nausea - Vaccination Period 1	6 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Headache - Vaccination Period 1	21 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Fatigue - Vaccination Period 2	15 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Chills - Vaccination Period 2	10 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Fever - Vaccination Period 1	6 Participants
Group 4 - Two High Doses	Solicited General Adverse Events	Nausea - Vaccination Period 2	6 Participants
Group 5 - Placebo	Solicited General Adverse Events	Fatigue - Vaccination Period 2	10 Participants
Group 5 - Placebo	Solicited General Adverse Events	Chills - Vaccination Period 1	3 Participants
Group 5 - Placebo	Solicited General Adverse Events	Fever - Vaccination Period 1	1 Participants
Group 5 - Placebo	Solicited General Adverse Events	Myalgia - Vaccination Period 2	8 Participants
Group 5 - Placebo	Solicited General Adverse Events	Fatigue - Vaccination Period 1	5 Participants
Group 5 - Placebo	Solicited General Adverse Events	Myalgia - Vaccination Period 1	7 Participants
Group 5 - Placebo	Solicited General Adverse Events	Nausea - Vaccination Period 2	1 Participants
Group 5 - Placebo	Solicited General Adverse Events	Headache - Vaccination Period 2	9 Participants
Group 5 - Placebo	Solicited General Adverse Events	Fever - Vaccination Period 2	0 Participants
Group 5 - Placebo	Solicited General Adverse Events	Headache - Vaccination Period 1	13 Participants
Group 5 - Placebo	Solicited General Adverse Events	Nausea - Vaccination Period 1	4 Participants
Group 5 - Placebo	Solicited General Adverse Events	Chills - Vaccination Period 2	7 Participants

Secondary

Solicited Local Adverse Events

Incidence of injection site reactions (solicited via diary cards) after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Time frame: within 8 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Swelling - Vaccination Period 1	11 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Pain - Booster Vaccination Period	24 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Pruritis - Booster Vaccination Period	3 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Erythema - Vaccination Period 1	15 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Pain - Vaccination Period 1	39 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Pruritis - Vaccination Period 1	3 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Induration - Booster Vaccination Period	7 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Erythema - Vaccination Period 2	5 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Induration - Vaccination Period 2	0 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Erythema - Booster Vaccination Period	9 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Pain - Vaccination Period 2	6 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Induration - Vaccination Period 1	9 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Swelling - Vaccination Period 2	1 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Swelling - Booster Vaccination Period	9 Participants
Group 1 - Single Low Dose / Booster	Solicited Local Adverse Events	Pruritis - Vaccination Period 2	2 Participants
Group 2 - Two Low Doses	Solicited Local Adverse Events	Pain - Vaccination Period 2	39 Participants
Group 2 - Two Low Doses	Solicited Local Adverse Events	Induration - Vaccination Period 1	5 Participants
Group 2 - Two Low Doses	Solicited Local Adverse Events	Induration - Vaccination Period 2	2 Participants
Group 2 - Two Low Doses	Solicited Local Adverse Events	Swelling - Vaccination Period 1	13 Participants
Group 2 - Two Low Doses	Solicited Local Adverse Events	Swelling - Vaccination Period 2	8 Participants
Group 2 - Two Low Doses	Solicited Local Adverse Events	Pain - Vaccination Period 1	57 Participants
Group 2 - Two Low Doses	Solicited Local Adverse Events	Erythema - Vaccination Period 1	13 Participants
Group 2 - Two Low Doses	Solicited Local Adverse Events	Erythema - Vaccination Period 2	13 Participants
Group 2 - Two Low Doses	Solicited Local Adverse Events	Pruritis - Vaccination Period 1	7 Participants
Group 2 - Two Low Doses	Solicited Local Adverse Events	Pruritis - Vaccination Period 2	10 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Erythema - Vaccination Period 1	24 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Pain - Vaccination Period 1	58 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Pain - Vaccination Period 2	6 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Pain - Booster Vaccination Period	39 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Erythema - Vaccination Period 2	6 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Erythema - Booster Vaccination Period	15 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Swelling - Vaccination Period 1	16 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Swelling - Vaccination Period 2	1 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Swelling - Booster Vaccination Period	15 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Induration - Vaccination Period 1	13 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Induration - Vaccination Period 2	3 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Induration - Booster Vaccination Period	13 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Pruritis - Vaccination Period 1	14 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Pruritis - Vaccination Period 2	2 Participants
Group 3 - Single High Dose / Booster	Solicited Local Adverse Events	Pruritis - Booster Vaccination Period	11 Participants
Group 4 - Two High Doses	Solicited Local Adverse Events	Erythema - Vaccination Period 2	17 Participants
Group 4 - Two High Doses	Solicited Local Adverse Events	Pruritis - Vaccination Period 1	7 Participants
Group 4 - Two High Doses	Solicited Local Adverse Events	Pain - Vaccination Period 1	76 Participants
Group 4 - Two High Doses	Solicited Local Adverse Events	Pruritis - Vaccination Period 2	5 Participants
Group 4 - Two High Doses	Solicited Local Adverse Events	Swelling - Vaccination Period 2	16 Participants
Group 4 - Two High Doses	Solicited Local Adverse Events	Pain - Vaccination Period 2	51 Participants
Group 4 - Two High Doses	Solicited Local Adverse Events	Erythema - Vaccination Period 1	19 Participants
Group 4 - Two High Doses	Solicited Local Adverse Events	Swelling - Vaccination Period 1	17 Participants
Group 4 - Two High Doses	Solicited Local Adverse Events	Induration - Vaccination Period 2	11 Participants
Group 4 - Two High Doses	Solicited Local Adverse Events	Induration - Vaccination Period 1	13 Participants
Group 5 - Placebo	Solicited Local Adverse Events	Pruritis - Vaccination Period 2	1 Participants
Group 5 - Placebo	Solicited Local Adverse Events	Erythema - Vaccination Period 2	8 Participants
Group 5 - Placebo	Solicited Local Adverse Events	Induration - Vaccination Period 2	3 Participants
Group 5 - Placebo	Solicited Local Adverse Events	Erythema - Vaccination Period 1	14 Participants
Group 5 - Placebo	Solicited Local Adverse Events	Pain - Vaccination Period 2	10 Participants
Group 5 - Placebo	Solicited Local Adverse Events	Induration - Vaccination Period 1	3 Participants
Group 5 - Placebo	Solicited Local Adverse Events	Pruritis - Vaccination Period 1	4 Participants
Group 5 - Placebo	Solicited Local Adverse Events	Swelling - Vaccination Period 2	1 Participants
Group 5 - Placebo	Solicited Local Adverse Events	Swelling - Vaccination Period 1	2 Participants
Group 5 - Placebo	Solicited Local Adverse Events	Pain - Vaccination Period 1	9 Participants

Secondary

Unsolicited Non-serious Adverse Events

Incidence of unsolicited non-serious adverse events by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.

Time frame: within 29 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1 - Single Low Dose / Booster	Unsolicited Non-serious Adverse Events	Vaccination Period 1	14 Participants
Group 1 - Single Low Dose / Booster	Unsolicited Non-serious Adverse Events	Vaccination Period 2	21 Participants
Group 1 - Single Low Dose / Booster	Unsolicited Non-serious Adverse Events	Booster Vaccination Period	1 Participants
Group 2 - Two Low Doses	Unsolicited Non-serious Adverse Events	Vaccination Period 2	23 Participants
Group 2 - Two Low Doses	Unsolicited Non-serious Adverse Events	Vaccination Period 1	23 Participants
Group 3 - Single High Dose / Booster	Unsolicited Non-serious Adverse Events	Booster Vaccination Period	3 Participants
Group 3 - Single High Dose / Booster	Unsolicited Non-serious Adverse Events	Vaccination Period 1	23 Participants
Group 3 - Single High Dose / Booster	Unsolicited Non-serious Adverse Events	Vaccination Period 2	26 Participants
Group 4 - Two High Doses	Unsolicited Non-serious Adverse Events	Vaccination Period 2	21 Participants
Group 4 - Two High Doses	Unsolicited Non-serious Adverse Events	Vaccination Period 1	22 Participants
Group 5 - Placebo	Unsolicited Non-serious Adverse Events	Vaccination Period 2	27 Participants
Group 5 - Placebo	Unsolicited Non-serious Adverse Events	Vaccination Period 1	21 Participants

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026

RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

PRNT (Subtype A) GMT

ELISA (IgA) GMT

ELISA (IgG) GMT

ELISA (Mucosal IgA) GMT

ELISPOT (IFN-g, Peptide Pool: F) GMSFU

ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU

ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU

ELISPOT (IFN-g, Peptide Pool: M2) GMSFU

ELISPOT (IFN-g, Peptide Pool: N) GMSFU

ELISPOT (IL-4, Peptide Pool: F) GMSFU

ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU

ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU

ELISPOT (IL-4, Peptide Pool: M2) GMSFU

ELISPOT (IL-4, Peptide Pool: N) GMSFU

Grade ≥ 3 Serious Adverse Events

Grade ≥ 3 Solicited General Adverse Events

Grade ≥ 3 Solicited Local Adverse Events

Grade ≥ 3 Unsolicited Non-serious Adverse Events

Memory B Cells (IgG) GMSFU

Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)

Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))

Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))

Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)

Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)

Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)

Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))

Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))

Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)

Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)

Percentage of Participants With Response by IgA ELISA

Percentage of Participants With Response by IgG ELISA

Percentage of Participants With Response by Mucosal IgA ELISA

Percentage of Participants With Response by PRNT (Subtype A)

Percentage of Participants With Response by PRNT (Subtype B)

PRNT (Subtype A) GMT

PRNT (Subtype B) GMT

Related Grade ≥ 3 Adverse Events

Related Serious Adverse Events

Related Solicited General Adverse Events

Related Unsolicited Non-serious Adverse Events

Serious Adverse Events

Solicited General Adverse Events

Solicited Local Adverse Events

Unsolicited Non-serious Adverse Events