Smallpox
Conditions
Brief summary
This is a Phase 3 multicenter trial to evaluate safety and immune response of three consecutive production lots of freeze-dried (FD) MVA-BN smallpox vaccine. The vaccine will be given to healthy subjects who do not have a smallpox scar. Approximately 1110 subjects will be randomly enrolled into one of three groups: Group 1 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 1). Group 2 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 2). Group 3 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 3). The primary objective of the trial is to show that the immune response elicited (produced) by three consecutively produced MVA-BN lots are statistically (numerically) comparable.
Interventions
BIOLOGICALFD MVA-BN
Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Sponsors
Biomedical Advanced Research and Development Authority
Bavarian Nordic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject has read, signed and dated the ICF * Body Mass Index ≥ 18.5 and \< 35 * Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal (defined as ≥ 12 months without a menstrual period) or surgically sterilized. Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products). * WOCBP must have a negative serum pregnancy test at screening (please note: a negative urine pregnancy test is required within 24 hours prior to each vaccination) * White blood cells ≥ 2500/mm3 \< ULN (Upper Limit of Normal) * Absolute neutrophil count (ANC) within normal limits * Hemoglobin within normal limits * Platelets within normal limits * Adequate renal function defined as a calculated Creatinine Clearance (CrCl) \> 60 mL/min as estimated by the Cockcroft-Gault equation: (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min). For women the result, calculated with the above formula, has to be multiplied by 0.85 = CrCl (mL/min) * Adequate hepatic function defined as: Total bilirubin ≤ 1.5 x ULN in the absence of other evidence of significant liver disease Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 1.5 x ULN * Electrocardiogram (ECG) without clinically significant findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions in a row, ST elevation consistent with ischemia).
Exclusion criteria
* Typical vaccinia scar * Known or suspected history of smallpox vaccination * History of vaccination with any poxvirus-based vaccine * US Military service prior to 1991 or after January 2003 * Pregnant or breast-feeding women * Uncontrolled serious infection, i.e. not responding to antimicrobial therapy * History 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 or active autoimmune disease, persons with vitiligo or thyroid disease taking thyroid replacement are not excluded * Known or suspected impairment of immunologic function including, but not limited to, human immunodeficiency virus (HIV) Infection, clinically significant liver disease (including chronic active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection), diabetes mellitus * History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site. * History or clinical manifestation of clinically significant and severe hematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders * Clinically significant mental disorder not adequately controlled by medical treatment * History of coronary heart disease, myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor * Abnormal Troponin I level \> ULN * Known history of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years * Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the past 6 months) * Known allergy to MVA-BN vaccine or any of its constituents, e.g. tris (hydroxymethyl)-amino methane, including known allergy to egg or aminoglycosides * History of anaphylaxis or severe allergic reaction to any vaccine * Acute disease (illness with or without a fever) at the time enrollment * Body temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrollment * 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 a killed/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 administration of the vaccine and ending at last physical trial visit (Visit 5) * Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy * Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (Visit 5) * Use of any investigational or non-registered product within 30 days preceding the first dose of the trial vaccine, or planned administration of such a drug during the trial period * Trial personnel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccinia-Specific Neutralizing Antibodies Measured by Plaque Reduction Neutralization Test (PRNT) | Two weeks post second vaccination; approximately Week 6. | Vaccinia-specific neutralizing antibody titers below the lower limit of quantitation are given a value 10, i.e., half of the PRNT lower limit of quantitation of 20. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Rates for Vaccinia-Specific Neutralizing Antibodies by PRNT | Two weeks post second vaccination; approximately Week 6. | Seroconversion is defined as either the appearance of antibody titers \>= LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline. The LLOQ for PRNT is 20. |
| Seroconversion Rates for Vaccinia-Specific Total Antibodies by ELISA | Two weeks post second vaccination; approximately Week 6. | Seroconversion is defined as either the appearance of antibody titers \>= LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline. The LLOQ for ELISA is 200. |
| Pearson Correlation Coefficient Between the log10 Transformed PRNT Titers and the log10 Transformed ELISA Titers | Two weeks post second vaccination; approximately Week 6. | Pearson correlation coefficient calculated on the log10 PRNT vs. ELISA titers at 2 weeks post second vaccination. |
| Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial | Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination. | Occurrence is defined as the number of participants who experienced an SAE. Related SAEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening. |
| Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial. | Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination. | Occurrence is defined as the number of participants who experienced an event falling in the system organ class of Cardiac disorders per MedDRA version 22.0. Related cardiac signs and symptoms are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening. |
| Vaccinia-Specific Total Antibodies Measured by Enzyme-Linked Immunosorbant Assay (ELISA) | Two weeks post second vaccination; approximately Week 6. | Vaccinia-specific total antibody titers below the lower limit of quantitation are given a value 100, i.e., half of the ELISA lower limit of quantitation of 200. |
| Occurrence, Relationship and Intensity of Unsolicited AEs | Within 28 days (and up to 35 days) after each vaccination, ie, from Visit 1 to Visit 3 for the first vaccination and from Visit 3 to Visit 5 for the second vaccination based on the protocol scheduled visits. | Occurrence is defined as the number of participants who experienced an unsolicited AE. Related unsolicited AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening. |
| Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | During the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits. | Occurrence is defined as the number of participants who experienced a solicited local AE. Intensity is defined per the protocol for each local event type. For injection site erythema, swelling, and induration the intensity is graded based on the maximum diameter as Grade 1: \< 30mm, Grade 2: \>= 30 - \< 100mm, Grade 3: \>= 100mm. Intensity for pruritis is defined as Grade 1: mild, Grade 2: moderate, Grade 3: severe. Intensity for injection site pain is defined as Grade 1: Painful on touch, Grade 2: Painful when moving the limb, Grade 3: Spontaneously painful/prevents normal activity. If a participant experienced the local event after both vaccinations, the maximum intensity is presented. |
| Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Starting during the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie, Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits, through resolution. | Number of days from the start of the local event to resolution. If a participant experienced the local event after both vaccinations, the longer duration is presented. Subjects who had a missing resolution date for the event are not included in the analysis. |
| Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | During the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits. | Occurrence is defined as the number of participants who experienced a solicited general AE. Related solicited general AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the protocol for each general event type. For pyrexia (increased body temperature) grading is defined as Grade 1: ≥ 99.5 - \< 100.4°F (≥ 37.5 - \< 38.0°C), Grade 2:≥ 100.4 - \< 102.2°F (≥ 38.0 - \< 39.0°C), Grade 3:≥ 102.2 - \< 104°F (≥ 39.0 - \< 40.0°C), and Grade 4: ≥ 104°F (≥ 40.0°C). Intensity for headache, myalgia, nausea, fatigue and chills is defined as Grade 1: mild, Grade 2: moderate, Grade 3: severe. If a participant experienced the general event after both vaccinations, the maximum intensity is presented. |
| Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Starting during the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie, Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits, through resolution. | Number of days from the start of the general event to resolution. If a participant experienced the general event after both vaccinations, the longer duration is presented. Subjects who had a missing resolution date for the event are not included in the analysis. |
| Occurrence of Any Grade 3 or 4 Unsolicited AEs Probably, Possibly or Definitely Related to the Trial Vaccine | Within 28 days (and up to 35 days) after each vaccination, ie, from Visit 1 to Visit 3 for the first vaccination and from Visit 3 to Visit 5 for the second vaccination based on the protocol scheduled visits. | Related AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where Grade 3 is Severe and Grade 4 is Potentially Life Threatening. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1
FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U) | 377 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2
FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U) | 375 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3
FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U) | 377 |
| Total | 1,129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 5 | 2 |
| Overall Study | Death | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 20 | 16 | 15 |
| Overall Study | Other reasons | 5 | 3 | 10 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 13 | 14 | 13 |
Baseline characteristics
| Characteristic | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 377 Participants | 375 Participants | 377 Participants | 1129 Participants |
| Age, Continuous | 30.7 years STANDARD_DEVIATION 7.31 | 30.6 years STANDARD_DEVIATION 7.29 | 30.7 years STANDARD_DEVIATION 7.5 | 30.7 years STANDARD_DEVIATION 7.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 20 Participants | 25 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 348 Participants | 354 Participants | 349 Participants | 1051 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 13 Participants | 13 Participants | 43 Participants |
| Race (NIH/OMB) Black or African American | 58 Participants | 55 Participants | 59 Participants | 172 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 9 Participants | 8 Participants | 24 Participants |
| Race (NIH/OMB) White | 292 Participants | 295 Participants | 293 Participants | 880 Participants |
| Region of Enrollment United States | 377 participants | 375 participants | 377 participants | 1129 participants |
| Sex: Female, Male Female | 210 Participants | 213 Participants | 207 Participants | 630 Participants |
| Sex: Female, Male Male | 167 Participants | 162 Participants | 170 Participants | 499 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 377 | 2 / 375 | 0 / 377 |
| other Total, other adverse events | 347 / 377 | 353 / 375 | 349 / 377 |
| serious Total, serious adverse events | 1 / 377 | 7 / 375 | 1 / 377 |
Outcome results
Primary
Vaccinia-Specific Neutralizing Antibodies Measured by Plaque Reduction Neutralization Test (PRNT)
Vaccinia-specific neutralizing antibody titers below the lower limit of quantitation are given a value 10, i.e., half of the PRNT lower limit of quantitation of 20.
Time frame: Two weeks post second vaccination; approximately Week 6.
Population: The Per Protocol Set includes all randomized subjects who received at least one vaccination and had no major protocol deviations that might have a substantial impact on the immunogenicity results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Vaccinia-Specific Neutralizing Antibodies Measured by Plaque Reduction Neutralization Test (PRNT) | 252.7 Titer |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Vaccinia-Specific Neutralizing Antibodies Measured by Plaque Reduction Neutralization Test (PRNT) | 269.9 Titer |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Vaccinia-Specific Neutralizing Antibodies Measured by Plaque Reduction Neutralization Test (PRNT) | 242.0 Titer |
95% CI: [0.816, 1.073]
95% CI: [0.967, 1.287]
95% CI: [0.915, 1.191]
Secondary
Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills)
Number of days from the start of the general event to resolution. If a participant experienced the general event after both vaccinations, the longer duration is presented. Subjects who had a missing resolution date for the event are not included in the analysis.
Time frame: Starting during the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie, Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits, through resolution.
Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Pyrexia | 2.3 Days | Standard Deviation 1.87 |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Headache | 3.2 Days | Standard Deviation 2.85 |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Myalgia | 4.1 Days | Standard Deviation 2.8 |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Nausea | 2.6 Days | Standard Deviation 2.98 |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Fatigue | 3.9 Days | Standard Deviation 5.16 |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Chills | 2.3 Days | Standard Deviation 2.01 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Chills | 2.3 Days | Standard Deviation 2.71 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Pyrexia | 1.9 Days | Standard Deviation 1.91 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Nausea | 2.7 Days | Standard Deviation 2.76 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Fatigue | 3.1 Days | Standard Deviation 2.7 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Headache | 3.1 Days | Standard Deviation 2.49 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Myalgia | 4 Days | Standard Deviation 3.27 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Headache | 3.2 Days | Standard Deviation 3.59 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Myalgia | 4.1 Days | Standard Deviation 3.3 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Chills | 2.3 Days | Standard Deviation 2.19 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Nausea | 2.7 Days | Standard Deviation 2.5 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Pyrexia | 1.9 Days | Standard Deviation 1.92 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills) | Fatigue | 3.6 Days | Standard Deviation 3.57 |
Secondary
Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Number of days from the start of the local event to resolution. If a participant experienced the local event after both vaccinations, the longer duration is presented. Subjects who had a missing resolution date for the event are not included in the analysis.
Time frame: Starting during the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie, Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits, through resolution.
Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pain | 6.9 Days | Standard Deviation 4.41 |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration | 18 Days | Standard Deviation 24.04 |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness | 7.1 Days | Standard Deviation 6.53 |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis | 5 Days | Standard Deviation 5.7 |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling | 6.7 Days | Standard Deviation 6.47 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pain | 7.1 Days | Standard Deviation 4.44 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness | 6.5 Days | Standard Deviation 5.06 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling | 6 Days | Standard Deviation 5.04 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration | 13.9 Days | Standard Deviation 13.12 |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis | 4.4 Days | Standard Deviation 3.24 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness | 6.6 Days | Standard Deviation 5.39 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis | 4.4 Days | Standard Deviation 3.87 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling | 5.9 Days | Standard Deviation 4.52 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pain | 6.7 Days | Standard Deviation 3.64 |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration | 15 Days | Standard Deviation 15.01 |
Secondary
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Occurrence is defined as the number of participants who experienced a solicited local AE. Intensity is defined per the protocol for each local event type. For injection site erythema, swelling, and induration the intensity is graded based on the maximum diameter as Grade 1: \< 30mm, Grade 2: \>= 30 - \< 100mm, Grade 3: \>= 100mm. Intensity for pruritis is defined as Grade 1: mild, Grade 2: moderate, Grade 3: severe. Intensity for injection site pain is defined as Grade 1: Painful on touch, Grade 2: Painful when moving the limb, Grade 3: Spontaneously painful/prevents normal activity. If a participant experienced the local event after both vaccinations, the maximum intensity is presented.
Time frame: During the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits.
Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling Grade 2 | 110 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Injection Site Pain Grade 1 | 118 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis Grade 1 | 160 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling Grade 3 | 17 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness Grade 2 | 143 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Pruritis | 210 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Induration | 215 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Injection Site Pain Grade 3 | 46 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration Grade 3 | 11 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration Grade 1 | 98 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Injection Site Pain | 325 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration Grade 2 | 106 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness Grade 3 | 44 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Injection Site Pain Grade 2 | 161 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Solicited Local AEs | 338 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Swelling | 215 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness Grade 1 | 84 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis Grade 3 | 10 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling Grade 1 | 88 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Redness | 271 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis Grade 2 | 40 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis Grade 3 | 7 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Solicited Local AEs | 348 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Redness | 283 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness Grade 1 | 110 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness Grade 2 | 131 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness Grade 3 | 42 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Swelling | 233 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling Grade 1 | 121 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling Grade 2 | 87 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling Grade 3 | 25 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Induration | 226 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration Grade 1 | 126 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration Grade 2 | 92 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration Grade 3 | 8 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Pruritis | 230 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis Grade 1 | 181 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Injection Site Pain | 330 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Injection Site Pain Grade 1 | 112 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Injection Site Pain Grade 2 | 173 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Injection Site Pain Grade 3 | 45 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis Grade 2 | 42 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling Grade 2 | 106 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Injection Site Pain Grade 3 | 43 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis Grade 1 | 159 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling Grade 1 | 118 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis Grade 2 | 29 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Swelling | 236 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness Grade 3 | 29 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Pruritis Grade 3 | 10 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness Grade 2 | 156 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Injection Site Pain Grade 2 | 162 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Injection Site Pain | 329 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Redness Grade 1 | 87 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration Grade 1 | 123 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Solicited Local AEs | 344 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration Grade 2 | 100 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Induration | 229 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Injection Site Pain Grade 1 | 124 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Induration Grade 3 | 6 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Swelling Grade 3 | 12 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Redness | 272 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain). | Any Pruritis | 198 Participants |
Secondary
Occurrence of Any Grade 3 or 4 Unsolicited AEs Probably, Possibly or Definitely Related to the Trial Vaccine
Related AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where Grade 3 is Severe and Grade 4 is Potentially Life Threatening.
Time frame: Within 28 days (and up to 35 days) after each vaccination, ie, from Visit 1 to Visit 3 for the first vaccination and from Visit 3 to Visit 5 for the second vaccination based on the protocol scheduled visits.
Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence of Any Grade 3 or 4 Unsolicited AEs Probably, Possibly or Definitely Related to the Trial Vaccine | 2 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence of Any Grade 3 or 4 Unsolicited AEs Probably, Possibly or Definitely Related to the Trial Vaccine | 0 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence of Any Grade 3 or 4 Unsolicited AEs Probably, Possibly or Definitely Related to the Trial Vaccine | 1 Participants |
Secondary
Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial.
Occurrence is defined as the number of participants who experienced an event falling in the system organ class of Cardiac disorders per MedDRA version 22.0. Related cardiac signs and symptoms are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.
Time frame: Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial. | Any Related Cardiac Sign or Symptom | 0 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial. | Any Cardiac Sign or Symptom | 1 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial. | Any Cardiac Sign or Symptom >=Grade 3 | 0 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial. | Any Related Cardiac Sign or Symptom | 0 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial. | Any Cardiac Sign or Symptom | 2 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial. | Any Cardiac Sign or Symptom >=Grade 3 | 0 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial. | Any Cardiac Sign or Symptom | 1 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial. | Any Cardiac Sign or Symptom >=Grade 3 | 0 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial. | Any Related Cardiac Sign or Symptom | 0 Participants |
Secondary
Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial
Occurrence is defined as the number of participants who experienced an SAE. Related SAEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.
Time frame: Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial | Related Serious Adverse Event | 0 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial | Any Serious Adverse Event | 1 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial | Serious Adverse Event >= Grade 3 | 0 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial | Related Serious Adverse Event | 0 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial | Any Serious Adverse Event | 7 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial | Serious Adverse Event >= Grade 3 | 5 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial | Any Serious Adverse Event | 1 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial | Serious Adverse Event >= Grade 3 | 1 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial | Related Serious Adverse Event | 0 Participants |
Secondary
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Occurrence is defined as the number of participants who experienced a solicited general AE. Related solicited general AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the protocol for each general event type. For pyrexia (increased body temperature) grading is defined as Grade 1: ≥ 99.5 - \< 100.4°F (≥ 37.5 - \< 38.0°C), Grade 2:≥ 100.4 - \< 102.2°F (≥ 38.0 - \< 39.0°C), Grade 3:≥ 102.2 - \< 104°F (≥ 39.0 - \< 40.0°C), and Grade 4: ≥ 104°F (≥ 40.0°C). Intensity for headache, myalgia, nausea, fatigue and chills is defined as Grade 1: mild, Grade 2: moderate, Grade 3: severe. If a participant experienced the general event after both vaccinations, the maximum intensity is presented.
Time frame: During the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits.
Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Pyrexia | 47 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Chills | 58 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Headache Grade 3 | 14 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Fatigue Grade 2 | 43 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 1 | 39 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Headache | 140 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Headache Grade 1 | 96 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Chills Grade 1 | 43 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Myalgia | 166 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Pyrexia | 47 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Nausea Grade 2 | 16 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Myalgia Grade 1 | 115 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Fatigue Grade 1 | 82 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 2 | 7 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Myalgia Grade 2 | 38 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Chills Grade 2 | 10 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Fatigue | 140 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Myalgia Grade 3 | 13 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Headache | 146 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Fatigue Grade 3 | 15 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Myalgia | 159 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Chills Grade 3 | 5 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 3 | 1 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Nausea | 75 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Fatigue | 135 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Headache Grade 2 | 36 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Nausea Grade 1 | 53 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Chills | 55 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Solicited General AEs | 246 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Nausea | 73 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 4 | 0 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Nausea Grade 3 | 6 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Solicited General AEs | 253 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Nausea Grade 3 | 6 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Nausea | 73 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Solicited General AEs | 256 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Fatigue | 171 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Fatigue Grade 1 | 111 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Pyrexia | 57 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Fatigue Grade 2 | 47 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Solicited General AEs | 267 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Fatigue Grade 3 | 13 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Fatigue | 163 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Chills | 54 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Chills Grade 1 | 28 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Headache Grade 1 | 102 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Chills Grade 2 | 22 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Pyrexia | 60 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Chills Grade 3 | 4 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Chills | 50 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Headache Grade 2 | 44 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Headache | 157 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Headache Grade 3 | 11 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Headache | 145 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 1 | 48 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Myalgia | 173 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Myalgia Grade 1 | 116 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Myalgia Grade 2 | 47 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 2 | 8 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Myalgia Grade 3 | 10 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Myalgia | 167 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Nausea | 81 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 3 | 4 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Nausea Grade 1 | 56 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Nausea Grade 2 | 19 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 4 | 0 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Chills | 53 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Solicited General AEs | 266 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Solicited General AEs | 252 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Pyrexia | 63 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 1 | 49 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 2 | 13 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 3 | 1 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Pyrexia Grade 4 | 0 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Pyrexia | 55 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Headache | 155 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Headache Grade 1 | 120 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Headache Grade 2 | 25 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Headache Grade 3 | 10 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Headache | 145 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Myalgia | 175 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Myalgia Grade 1 | 116 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Myalgia Grade 2 | 39 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Myalgia Grade 3 | 20 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Myalgia | 167 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Nausea | 78 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Nausea Grade 1 | 54 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Nausea Grade 2 | 18 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Nausea Grade 3 | 6 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Nausea | 67 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Fatigue | 171 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Fatigue Grade 1 | 99 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Fatigue Grade 2 | 58 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Fatigue Grade 3 | 14 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Related Fatigue | 161 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Any Chills | 57 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Chills Grade 1 | 38 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Chills Grade 2 | 13 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills). | Chills Grade 3 | 6 Participants |
Secondary
Occurrence, Relationship and Intensity of Unsolicited AEs
Occurrence is defined as the number of participants who experienced an unsolicited AE. Related unsolicited AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.
Time frame: Within 28 days (and up to 35 days) after each vaccination, ie, from Visit 1 to Visit 3 for the first vaccination and from Visit 3 to Visit 5 for the second vaccination based on the protocol scheduled visits.
Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship and Intensity of Unsolicited AEs | Any Related Unsolicited AE | 33 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship and Intensity of Unsolicited AEs | Any Unsolicited AE | 88 Participants |
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Occurrence, Relationship and Intensity of Unsolicited AEs | Any Unsolicited AE >= Grade 3 | 6 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship and Intensity of Unsolicited AEs | Any Related Unsolicited AE | 38 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship and Intensity of Unsolicited AEs | Any Unsolicited AE | 110 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Occurrence, Relationship and Intensity of Unsolicited AEs | Any Unsolicited AE >= Grade 3 | 8 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship and Intensity of Unsolicited AEs | Any Unsolicited AE | 98 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship and Intensity of Unsolicited AEs | Any Unsolicited AE >= Grade 3 | 7 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Occurrence, Relationship and Intensity of Unsolicited AEs | Any Related Unsolicited AE | 37 Participants |
Secondary
Pearson Correlation Coefficient Between the log10 Transformed PRNT Titers and the log10 Transformed ELISA Titers
Pearson correlation coefficient calculated on the log10 PRNT vs. ELISA titers at 2 weeks post second vaccination.
Time frame: Two weeks post second vaccination; approximately Week 6.
Population: The Per Protocol Set includes all randomized subjects who received at least one vaccination and had no major protocol deviations that might have a substantial impact on the immunogenicity results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Pearson Correlation Coefficient Between the log10 Transformed PRNT Titers and the log10 Transformed ELISA Titers | 0.657 Correlation Coefficient |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Pearson Correlation Coefficient Between the log10 Transformed PRNT Titers and the log10 Transformed ELISA Titers | 0.657 Correlation Coefficient |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Pearson Correlation Coefficient Between the log10 Transformed PRNT Titers and the log10 Transformed ELISA Titers | 0.656 Correlation Coefficient |
Secondary
Seroconversion Rates for Vaccinia-Specific Neutralizing Antibodies by PRNT
Seroconversion is defined as either the appearance of antibody titers \>= LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline. The LLOQ for PRNT is 20.
Time frame: Two weeks post second vaccination; approximately Week 6.
Population: The Per Protocol Set includes all randomized subjects who received at least one vaccination and had no major protocol deviations that might have a substantial impact on the immunogenicity results. Only subjects who had both a baseline and two weeks post second vaccination titer results are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Seroconversion Rates for Vaccinia-Specific Neutralizing Antibodies by PRNT | 325 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Seroconversion Rates for Vaccinia-Specific Neutralizing Antibodies by PRNT | 328 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Seroconversion Rates for Vaccinia-Specific Neutralizing Antibodies by PRNT | 327 Participants |
Secondary
Seroconversion Rates for Vaccinia-Specific Total Antibodies by ELISA
Seroconversion is defined as either the appearance of antibody titers \>= LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline. The LLOQ for ELISA is 200.
Time frame: Two weeks post second vaccination; approximately Week 6.
Population: The Per Protocol Set includes all randomized subjects who received at least one vaccination and had no major protocol deviations that might have a substantial impact on the immunogenicity results. Only subjects who had both a baseline and two weeks post second vaccination titer results are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Seroconversion Rates for Vaccinia-Specific Total Antibodies by ELISA | 323 Participants |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Seroconversion Rates for Vaccinia-Specific Total Antibodies by ELISA | 325 Participants |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Seroconversion Rates for Vaccinia-Specific Total Antibodies by ELISA | 326 Participants |
Secondary
Vaccinia-Specific Total Antibodies Measured by Enzyme-Linked Immunosorbant Assay (ELISA)
Vaccinia-specific total antibody titers below the lower limit of quantitation are given a value 100, i.e., half of the ELISA lower limit of quantitation of 200.
Time frame: Two weeks post second vaccination; approximately Week 6.
Population: The Per Protocol Set includes all randomized subjects who received at least one vaccination and had no major protocol deviations that might have a substantial impact on the immunogenicity results.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | Vaccinia-Specific Total Antibodies Measured by Enzyme-Linked Immunosorbant Assay (ELISA) | 1222 Titer |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | Vaccinia-Specific Total Antibodies Measured by Enzyme-Linked Immunosorbant Assay (ELISA) | 1311 Titer |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | Vaccinia-Specific Total Antibodies Measured by Enzyme-Linked Immunosorbant Assay (ELISA) | 1226.1 Titer |