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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP 1: two doses of FD MVA-BN--Lot 1 | Active Comparator | Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 |
|
| GP 2: two doses of FD MVA-BN--Lot 2 | Active Comparator | Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 |
|
| GP 3: two doses of FD MVA-BN--Lot 3 | Active Comparator | Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FD MVA-BN | Biological | Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two weeks post second vaccination; approximately Week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two weeks post second vaccination; approximately Week 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edgar T Overton, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Optimal Research, LLC (Synexus) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36460535 | Derived | Turner Overton E, Schmidt D, Vidojkovic S, Menius E, Nopora K, Maclennan J, Weidenthaler H. A randomized phase 3 trial to assess the immunogenicity and safety of 3 consecutively produced lots of freeze-dried MVA-BN(R) vaccine in healthy adults. Vaccine. 2023 Jan 9;41(2):397-406. doi: 10.1016/j.vaccine.2022.10.056. Epub 2022 Nov 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Two weeks post second vaccination; approximately Week 6. |
|
Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
There were no limitations on the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bavarian Nordic Call Center | Bavarian Nordic A/S | 1-844-422-8274 | medical.information_us@bavarian-nordic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2019 | Feb 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2019 | Feb 2, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012899 | Smallpox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| 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. |
| Two weeks post second vaccination; approximately Week 6. |
| 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. | Two weeks post second vaccination; approximately Week 6. |
| 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. | Two weeks post second vaccination; approximately Week 6. |
| 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. | Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination. |
| 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. | Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination. |
| 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. | 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, 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. | 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 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| Melbourne |
| Florida |
| 32934 |
| United States |
| Optimal Research, LLC (Synexus) | Peoria | Illinois | 61614 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Kentucky Healthcare Chandler Hospital | Lexington | Kentucky | 40536 | United States |
| Optimal Research, LLC (Synexus) | Rockville | Maryland | 20850 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other reasons |
|
| 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) |
| BG002 | 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) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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) |
| OG002 | 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) |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Two weeks post second vaccination; approximately Week 6. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Two weeks post second vaccination; approximately Week 6. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Two weeks post second vaccination; approximately Week 6. |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Correlation Coefficient | Two weeks post second vaccination; approximately Week 6. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Days | 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. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Days | 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. |
|
|
|
| 0 |
| 377 |
| 1 |
| 377 |
| 347 |
| 377 |
| EG001 | 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) | 2 | 375 | 7 | 375 | 353 | 375 |
| EG002 | 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) | 0 | 377 | 1 | 377 | 349 | 377 |
| Colitis | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA version 22.0 | Non-systematic Assessment | Including death during follow-up |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 22.0 | Non-systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment | From follow-up |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 22.0 | Non-systematic Assessment | From follow-up |
|
| Panic attack | Psychiatric disorders | MedDRA version 22.0 | Non-systematic Assessment | From follow-up |
|
| Nausea | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Injection site pruritis | General disorders | MedDRA version 22.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA version 22.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 22.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
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The agreement entitles Bavarian Nordic to request the Institution(s) to delay their publication for a period of up to six (6) months from the date of the first submission to Bavarian Nordic.
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| Serious Adverse Event >= Grade 3 |
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| Any Cardiac Sign or Symptom >=Grade 3 |
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| Any Unsolicited AE >= Grade 3 |
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| Redness Grade 1 |
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| Redness Grade 2 |
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| Redness Grade 3 |
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| Any Swelling |
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| Swelling Grade 1 |
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| Swelling Grade 2 |
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| Swelling Grade 3 |
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| Any Induration |
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| Induration Grade 1 |
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| Induration Grade 2 |
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| Induration Grade 3 |
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| Any Pruritis |
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| Pruritis Grade 1 |
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| Pruritis Grade 2 |
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| Pruritis Grade 3 |
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| Any Injection Site Pain |
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| Injection Site Pain Grade 1 |
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| Injection Site Pain Grade 2 |
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| Injection Site Pain Grade 3 |
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| Swelling |
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| Induration |
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| Pruritis |
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| Pain |
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| Any Pyrexia |
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| Pyrexia Grade 1 |
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| Pyrexia Grade 2 |
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| Pyrexia Grade 3 |
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| Pyrexia Grade 4 |
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| Any Related Pyrexia |
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| Any Headache |
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| Headache Grade 1 |
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| Headache Grade 2 |
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| Headache Grade 3 |
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| Any Related Headache |
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| Any Myalgia |
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| Myalgia Grade 1 |
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| Myalgia Grade 2 |
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| Myalgia Grade 3 |
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| Any Related Myalgia |
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| Any Nausea |
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| Nausea Grade 1 |
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| Nausea Grade 2 |
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| Nausea Grade 3 |
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| Any Related Nausea |
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| Any Fatigue |
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| Fatigue Grade 1 |
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| Fatigue Grade 2 |
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| Fatigue Grade 3 |
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| Any Related Fatigue |
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| Any Chills |
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| Chills Grade 1 |
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| Chills Grade 2 |
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| Chills Grade 3 |
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| Any Related Chills |
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| Headache |
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| Myalgia |
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| Nausea |
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| Fatigue |
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| Chills |
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