RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults | NCT02873286 | Trialant
NCT02873286
Sponsor
Bavarian Nordic
Status
Completed
Last Update Posted
Sep 22, 2020Actual
Enrollment
420Actual
Phase
Phase 2
Conditions
Respiratory Syncytial Virus Infections
Interventions
MVA-BN-RSV
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02873286
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RSV-MVA-002
Secondary IDs
Not provided
Brief Title
RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults
Official Title
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
Acronym
Not provided
Organization
Bavarian NordicINDUSTRY
Status Module
Record Verification Date
Sep 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2016Actual
Primary Completion Date
Dec 2018Actual
Completion Date
Dec 2018Actual
First Submitted Date
Aug 9, 2016
First Submission Date that Met QC Criteria
Aug 16, 2016
First Posted Date
Aug 19, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 11, 2020
Results First Submitted that Met QC Criteria
Sep 1, 2020
Results First Posted Date
Sep 22, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 1, 2020
Last Update Posted Date
Sep 22, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bavarian NordicINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
Biological: MVA-BN-RSV
Group 5 - Placebo
Experimental
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MVA-BN-RSV
Biological
MVA-mBN294B
Group 1 - Single Low Dose / Booster
Group 2 - Two Low Doses
Group 3 - Single High Dose / Booster
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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)
Week 6 (Main Study) i.e., 2 weeks following the second vaccination
Secondary Outcomes
Measure
Description
Time Frame
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)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria (Main study):
Male and female subjects, ≥ 55 years of age.
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.
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.
Able to comply with trial requirements; including access to transportation for trial visits.
Body mass index (BMI) ≥ 18.5 and ≤ 39.9
BMI formula for pounds and inches:
BMI = (bodyweight in pounds) * 703 (bodyheight in inches)2
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
Not clinically significant laboratory values as defined in the protocol, excluding any Grade ≥ 3 toxicity.
Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody test to hepatitis C virus.
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):
Pregnant or breast-feeding women.
Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
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.
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.
Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I.
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.
Clinically significant mental disorder, not adequately controlled by medical treatment.
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.
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.
Known allergy to eggs or aminoglycosides.
History of anaphylaxis or severe allergic reaction to any vaccine.
Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination.
Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination.
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.
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.
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.
Previous or planned vaccination with a RSV vaccine/vaccine candidate.
Clinical trial personnel working on the current trial.
Inclusion Criteria (Substudy):
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.
Subject has completed all vaccinations of the main trial according to protocol.
Exclusion Criteria (Substudy):
Any condition that, in the opinion of the investigator, makes it unsafe for the subject to receive a further vaccination.
Pregnancy.
An anaphylactic reaction following the administration of any vaccine(s).
Clinical need for concomitant or ancillary therapy not permitted in the trial as outlined in Protocol Section 8.2.2.
Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after booster vaccination.
Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after booster vaccination.
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 3 months prior to administration of the booster vaccine and ending at the last visit of the booster active trial phase. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted.
Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the booster vaccine and ending at the last visit of the booster active trial phase.
Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the booster vaccination, or planned administration of such a drug during participation in the booster substudy and until 4 weeks after booster vaccination.
Subject's request to discontinue
Subject's refusal to receive booster vaccination.
Subject unwilling or unable to comply with trial requirements. Any reason that, in the opinion of the investigator contradicts administration of the booster vaccination or otherwise requires early discontinuation of a subject.
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)
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.
Posted
Geometric Mean
95% Confidence Interval
Titer
Week 6 (Main Study) i.e., 2 weeks following the second vaccination
108 weeks for participants of both study parts and 30 weeks for participants of the main study only
Description
Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
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.
within 108 weeks
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)
within 108 weeks
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.
within 108 weeks
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)
within 108 weeks
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.
within 108 weeks
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)
within 108 weeks
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.
within 108 weeks
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)
within 82 weeks
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.
within 82 weeks
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)
within 58 weeks
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)
within 58 weeks
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)
within 58 weeks
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)
within 58 weeks
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)
within 58 weeks
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)
within 58 weeks
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)
within 58 weeks
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)
within 58 weeks
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)
within 58 weeks
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)
within 58 weeks
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.
within 58 weeks
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.
within 58 weeks
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.
within 58 weeks
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.
within 58 weeks
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.
within 58 weeks
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.
within 58 weeks
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.
within 58 weeks
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.
within 58 weeks
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.
within 58 weeks
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.
within 58 weeks
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'
within 82 weeks
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.
within 108 weeks (Main Study + Booster Substudy)
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.
within 108 weeks (Main Study + Booster Substudy)
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.
within 108 weeks (Main Study + Booster Substudy)
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.
within 29 days after vaccination
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.
within 8 days after vaccination
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.
within 8 days after vaccination
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.
within 8 days after vaccination
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.
within 8 days after vaccination
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.
within 8 days after vaccination
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.
within 29 days after vaccination
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.
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.
within 29 days after vaccination
San Diego
California
92108
United States
Compass Research
The Villages
Florida
32162
United States
Meridian Clinical Research
Savannah
Georgia
31406
United States
Clinical Research Atlanta
Stockbridge
Georgia
30281
United States
Optimal Research
Peoria
Illinois
61614
United States
Optimal Research
Rockville
Maryland
20850
United States
Washington University in St. Louis, School of Medicine
St Louis
Missouri
63110
United States
United Medical Associates
Binghamton
New York
13901
United States
Regional Clinical Research Associates
Endwell
New York
13760
United States
Rapid Medical Research
Cleveland
Ohio
44122
United States
Ventavia Research Group
Fort Worth
Texas
76104
United States
83 subjects
FG00481 subjects
2 subjects
0 subjects
FG0040 subjects
COMPLETED
Completed substudy active trial phase
FG00043 subjects
FG0010 subjects
FG00245 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00076
OG00184
OG00278
OG00390
OG00481
Title
Denominators
Categories
Title
Measurements
OG000300.5(251.7 to 358.6)
OG001278.9(239.2 to 325.2)
OG002311.9(261.7 to 371.7)
OG003373.3(320.9 to 434.2)
OG004229.3(195.2 to 269.4)
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00078
ParticipantsOG00189
ParticipantsOG00280
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00188
OG00279
OG003
Title
Denominators
Categories
Week 2 (Main Study)
ParticipantsOG00078
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00078
ParticipantsOG00189
ParticipantsOG00280
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00188
OG00279
OG003
Title
Denominators
Categories
Week 2 (Main Study)
ParticipantsOG00078
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00078
ParticipantsOG00189
ParticipantsOG00280
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00188
OG00279
OG003
Title
Denominators
Categories
Week 2 (Main Study)
ParticipantsOG00078
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00078
ParticipantsOG00189
ParticipantsOG00280
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00188
OG00279
OG003
Title
Denominators
Categories
Week 2 (Main Study)
ParticipantsOG00078
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00077
OG00189
OG00280
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00076
ParticipantsOG00188
ParticipantsOG00279
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00076
OG00187
OG00278
OG003
Title
Denominators
Categories
Week 2 (Main Study)
ParticipantsOG00074
ParticipantsOG00183
ParticipantsOG00276
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG003
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)
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 1 (Main Study)
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 1 (Main Study)
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 1 (Main Study)
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 1 (Main Study)
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 1 (Main Study)
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 1 (Main Study)
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 1 (Main Study)
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 1 (Main Study)
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 1 (Main Study)
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00021
OG00122
OG00220
OG003
Title
Denominators
Categories
Week 1 (Main Study)
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG003
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'
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00013
OG00116
OG00215
OG003
Title
Denominators
Categories
Week 0 (Main Study)
ParticipantsOG00012
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Vaccination Period 1, Main Study
ParticipantsOG00078
ParticipantsOG00189
ParticipantsOG00280
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Vaccination Period 1, Main Study
ParticipantsOG00078
ParticipantsOG00189
ParticipantsOG00280
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Vaccination Period 1, Main Study
ParticipantsOG00078
ParticipantsOG00189
ParticipantsOG00280
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Vaccination Period 1, Main Study
ParticipantsOG00078
ParticipantsOG00189
ParticipantsOG00280
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Pain - Vaccination Period 1
ParticipantsOG00078
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Grade ≥ 3 Pain - Vaccination Period 1
ParticipantsOG00078
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Fever - Vaccination Period 1
ParticipantsOG00078
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Grade ≥ 3 Fever - Vaccination Period 1
ParticipantsOG00078
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Related Fever - Vaccination Period 1
ParticipantsOG00078
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
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.
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.
First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)
OG004
Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Units
Counts
Participants
OG00078
OG00189
OG00280
OG003
Title
Denominators
Categories
Vaccination Period 1
ParticipantsOG00078
ParticipantsOG00189
ParticipantsOG00280
ParticipantsOG003
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.
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.
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.
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.