Bacillus Anthracis (Anthrax) Infection
Conditions
Keywords
AVA, AV7909, Anthrax vaccine
Brief summary
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.
Detailed description
AV7909 is a new vaccine which is a combination of BioThrax (also called anthrax vaccine, adsorbed or AVA), a FDA-licensed vaccine, and CPG 7909. CPG 7909 is a synthetic short DNA sequence that has been shown to be an effective vaccine adjuvant, and one which increases the speed and the degree of the immune response to Protective Antigen (PA), the major vaccine antigen. In the current study, the safety, tolerability, and antibody response to PA will be studied for four different combinations of AVA and CPG 7909, and compared to both AVA and a saline placebo. All formulations of AV7909 have the same or less AVA than the licensed AVA vaccine and all have less CPG 7909 per dose than the formulation used in the first Phase I volunteer study of CPG 7909 combined with AVA.
Interventions
BIOLOGICALBioThrax
BioThrax
BIOLOGICALAV7909 Formulation 1
AV7909 Formulation 1
BIOLOGICALAV7909 Formulation 2
AV7909 Formulation 2
BIOLOGICALAV7909 Formulation 3
AV7909 Formulation 3
BIOLOGICALAV7909 Formulation 4
AV7909 Formulation 4
DRUGControl
Saline control
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Department of Health and Human Services
Emergent BioSolutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Be between 18 and 50 years of age, inclusive, at the time of enrollment. * Be in good health as determined by the investigator from medical history and a physical examination. * If a pre-menopausal female, must be using acceptable methods of birth control. * Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range. * Have negative values for the following tests at Screening: Hepatitis C antibody, anti-Human Immunodeficiency Virus (Anti-HIV-1/-2/-O), and anti-Hepatitis B Core Antigen (Anti-HBc). * Be willing and capable of complying with all aspects of the protocol through completion of the required visits. * Have not donated blood in the preceding 8 weeks and are willing to not donate blood or plasma within 56 days after dosing. * Have adequate venous access for repeat phlebotomies. * Have read, understood and signed an informed consent form.
Exclusion criteria
Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Days 0-56 | Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood. Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56. |
| Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Days 14-20 | Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia |
| Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Days 14-20 | Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia |
| Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Days 0-56 | Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood. Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56. |
| Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Days 0-6 | Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia |
| Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Days 0-6 | Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia |
| Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Days 14-20 | Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia |
| Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Days 14-20 | Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia |
| Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Days 0-6 | Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia |
| Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Days 0-6 | Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84. | Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation. |
| TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84. | Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation. |
| Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84. | Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the lower limit of quantitation (LLOQ) of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 27 December 2010 to 08 March 2012 at three medical centers in the U.S.
Pre-assignment details
All 105 enrolled participants who met inclusion and exclusion criteria were dosed.
Participants by arm
| Arm | Count |
|---|---|
| BioThrax Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 | 18 |
| AV7909 Formulation 1 Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 | 18 |
| AV7909 Formulation 2 Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 | 17 |
| AV7909 Formulation 3 Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 | 19 |
| AV7909 Formulation 4 Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 | 18 |
| Saline Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 | 15 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | BioThrax | AV7909 Formulation 4 | Saline | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 15 Participants | 18 Participants | 17 Participants | 18 Participants | 15 Participants | 100 Participants |
| Age, Continuous | 32.8 years STANDARD_DEVIATION 10.31 | 32.4 years STANDARD_DEVIATION 10.75 | 32.6 years STANDARD_DEVIATION 9.15 | 31.1 years STANDARD_DEVIATION 9.27 | 31.4 years STANDARD_DEVIATION 10.72 | 31.4 years STANDARD_DEVIATION 8.61 | 32.0 years STANDARD_DEVIATION 9.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 6 Participants | 4 Participants | 3 Participants | 3 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 11 Participants | 13 Participants | 14 Participants | 15 Participants | 12 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 6 Participants | 2 Participants | 3 Participants | 2 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 17 Participants | 15 Participants | 12 Participants | 15 Participants | 15 Participants | 13 Participants | 87 Participants |
| Region of Enrollment United States | 18 participants | 17 participants | 19 participants | 18 participants | 18 participants | 15 participants | 105 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 8 Participants | 9 Participants | 9 Participants | 7 Participants | 51 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 11 Participants | 9 Participants | 9 Participants | 8 Participants | 54 Participants |
| Weight | 83.99 kilograms STANDARD_DEVIATION 16.137 | 75.75 kilograms STANDARD_DEVIATION 12.232 | 78.39 kilograms STANDARD_DEVIATION 19.021 | 80.06 kilograms STANDARD_DEVIATION 18.799 | 76.24 kilograms STANDARD_DEVIATION 15.649 | 79.74 kilograms STANDARD_DEVIATION 23.14 | 79.03 kilograms STANDARD_DEVIATION 17.487 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 18 | 18 / 18 | 14 / 17 | 14 / 19 | 18 / 18 | 9 / 15 |
| serious Total, serious adverse events | 0 / 18 | 1 / 18 | 1 / 17 | 0 / 19 | 0 / 18 | 1 / 15 |
Outcome results
Primary
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood. Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56.
Time frame: Days 0-56
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 2 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 1 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 0 participants |
| BioThrax | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 0 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 6 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 1 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 0 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 5 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 0 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 0 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 0 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 1 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 0 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 1 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 0 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 0 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 0 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 1 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 1 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 1 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 0 participants |
| AV7909 Formulation 1 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 1 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 1 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 1 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 0 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 0 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 3 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 0 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 1 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 0 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 0 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 1 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 0 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 1 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 0 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 0 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 0 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 0 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 4 participants |
| AV7909 Formulation 2 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 1 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 2 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 1 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 1 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 1 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 0 participants |
| AV7909 Formulation 3 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 1 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 4 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 2 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 2 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 1 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 0 participants |
| AV7909 Formulation 4 | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 1 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 1 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 1 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 1 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 1 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 0 participants |
| Saline | Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 0 participants |
Primary
Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 0-6
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 9 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 8 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 11 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 4 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 7 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 5 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 9 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 10 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 6 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 1 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 2 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 13 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 8 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 5 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 1 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 2 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 1 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 9 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 0 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 2 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 4 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 16 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 3 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 13 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 2 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 14 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 12 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 2 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 17 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 2 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 1 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 11 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 7 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 1 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 10 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 12 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 1 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 8 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 2 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 1 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 1 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 11 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 13 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 2 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 1 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 1 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 2 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 12 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 1 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 11 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 7 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 2 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 1 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 12 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 10 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 8 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 4 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 1 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 9 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 2 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 1 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 5 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 6 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 6 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 10 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 16 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 11 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 5 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 1 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 1 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 2 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 1 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 1 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 13 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 2 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 11 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 8 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 3 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 6 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 4 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 11 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 1 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 1 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 1 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 1 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 0 Participants |
Primary
Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 14-20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 8 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 2 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 6 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 11 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 11 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 4 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 3 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 4 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 8 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Redness | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 2 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 2 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 2 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 1 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 3 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 2 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 6 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 0 Participants |
| BioThrax | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 2 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 4 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Redness | 0 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 3 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 0 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 4 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 3 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 1 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 8 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 13 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 5 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 0 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 13 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 10 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 2 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 1 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 3 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 2 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 1 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 11 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 6 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 1 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 3 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 0 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 16 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 8 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 6 Participants |
| AV7909 Formulation 1 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 2 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 6 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 7 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 3 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 3 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 3 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 12 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 11 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 10 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 2 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 2 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 9 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 10 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 11 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 1 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 2 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 2 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Redness | 0 Participants |
| AV7909 Formulation 2 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 8 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 2 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 8 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 2 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 6 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 6 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 2 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 2 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 1 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 2 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 2 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 8 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 3 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 4 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 2 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 3 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 1 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 3 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Redness | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 0 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 10 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 11 Participants |
| AV7909 Formulation 3 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 2 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Redness | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 1 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 6 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 5 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 1 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 9 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 3 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 13 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 6 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 8 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 12 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 3 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 7 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 3 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 0 Participants |
| AV7909 Formulation 4 | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 3 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Redness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 0 Participants |
| Saline | Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 0 Participants |
Primary
Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 0-6
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 4 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 0 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 6 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 10 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 8 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 0 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 6 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 0 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 0 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 4 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 1 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 0 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reaction | 2 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 6 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 5 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 1 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 1 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 0 Participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 0 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 5 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 6 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 11 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 2 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reaction | 7 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 12 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 1 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 0 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 2 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 3 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 4 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 2 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 0 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 9 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 5 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 4 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 7 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 4 Participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 8 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 3 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 3 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 0 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 2 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reaction | 2 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 3 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 1 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 5 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 5 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 2 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 2 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 1 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 1 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 1 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 2 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 0 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 2 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 0 Participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 7 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 2 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 3 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 3 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reaction | 0 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 0 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 0 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 0 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 3 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 3 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 0 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 0 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 0 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 0 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 1 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 1 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 0 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 0 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 2 Participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 0 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 5 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 2 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 2 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 1 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 2 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 7 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 3 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 4 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 0 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 1 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 0 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 1 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 2 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reaction | 4 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 0 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 2 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 0 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 2 Participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 2 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 0 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 2 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 2 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 0 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 1 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 5 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 0 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 1 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 2 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 1 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 2 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 1 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 2 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 1 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reaction | 1 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 2 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 2 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 1 Participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 4 Participants |
Primary
Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 14-20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 0 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 5 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 1 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 0 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 3 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 1 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 2 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 0 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 2 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 7 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 1 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 0 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 1 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 1 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 3 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 3 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 4 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 5 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 1 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 1 participants |
| BioThrax | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 3 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 3 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 9 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 7 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 14 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 5 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 1 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 0 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 1 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 5 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 1 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 2 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 0 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 5 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 8 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 0 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 5 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 2 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 3 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 2 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 1 participants |
| AV7909 Formulation 1 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 8 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 0 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 3 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 1 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 4 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 1 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 2 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 0 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 6 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 0 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 3 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 0 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 0 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 0 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 0 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 3 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 0 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 1 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 7 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 0 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 3 participants |
| AV7909 Formulation 2 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 0 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 1 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 0 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 1 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 3 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 2 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 2 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 4 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 0 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 2 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 0 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 0 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 0 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 0 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 0 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 3 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 1 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 2 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 0 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 0 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 2 participants |
| AV7909 Formulation 3 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 1 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 0 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 0 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 9 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 4 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 5 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 1 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 1 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 7 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 4 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 3 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 0 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 7 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 4 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 3 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 0 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 7 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 3 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 4 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 3 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 2 participants |
| AV7909 Formulation 4 | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 1 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 1 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 1 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 1 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 1 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 1 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 2 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 1 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 0 participants |
| Saline | Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 0 participants |
Primary
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood. Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56.
Time frame: Days 0-56
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 11.1 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 5.6 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 27.8 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 5.6 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 33.3 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 5.6 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 5.6 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 5.6 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 5.6 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 5.6 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 23.5 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 17.6 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 5.3 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 10.5 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 5.3 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 5.3 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 5.3 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 11.1 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 11.1 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 5.6 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 5.6 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 22.2 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Lymphocyte count decreased | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutropenia | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood lactate dehydrogenase increased | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hepatic enzyme increased | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Neutrophil count decreased | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Aspartate aminotransferase increased | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Alanine aminotransferase increased | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Protein urine | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood creatinine increased | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Red blood cells urine positive | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypomagnesemia | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cells urine positive | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count decreased | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hyperkalemia | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypokalemia | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Hypoglycemia | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | Blood urea increased | 0 percentage of participants |
| Saline | Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events | White blood cell count increased | 0 percentage of participants |
Primary
Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 0-6
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 38.9 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 44.4 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 50.0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 50.0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 55.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 22.2 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 61.1 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 27.8 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 5.6 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 11.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 72.2 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 11.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 88.9 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 11.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 50.0 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 94.4 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 11.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 44.4 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 72.2 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 5.6 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 5.6 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 5.6 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 33.3 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 11.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 11.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 22.2 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 27.8 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 66.7 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 77.8 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 16.7 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 5.6 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 70.6 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 11.8 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 5.9 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 5.9 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 5.9 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 58.8 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 5.9 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 70.6 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 11.8 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 11.8 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 47.1 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 76.5 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 64.7 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 5.9 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 64.7 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 41.2 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 5.9 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 5.3 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 31.6 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 5.3 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 26.3 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 5.3 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 21.1 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 47.4 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 10.5 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 63.2 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 57.9 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 5.3 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 42.1 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 31.6 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 10.5 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 52.6 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 36.8 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 61.1 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 11.1 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 55.6 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 44.4 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 16.7 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 5.6 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 61.1 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 5.6 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 33.3 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 88.9 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 22.2 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 61.1 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 27.8 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 72.2 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 5.6 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 11.1 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 5.6 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Pain | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Itching | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Swelling | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Tenderness | 6.7 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Reaction | 6.7 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Itching | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Swelling | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Pain | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Swelling | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Arm Motion Limitation | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Pain | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 3 Injection Site Reaction | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Tenderness | 6.7 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Injection Site Reaction | 6.7 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Swelling | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Arm Motion Limitation | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Arm Motion Limitation | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Injection Site Reaction | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Any Redness | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Injection Site Itching | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Tenderness | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 1 Redness | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) | Grade 2 Redness | 0 Percentage of Participants |
Primary
Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 14-20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 11.1 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 11.1 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 44.4 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 22.2 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 61.1 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 61.1 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 16.7 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 33.3 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 11.1 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 33.3 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 11.1 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 44.4 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 16.7 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 5.6 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 0 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 11.1 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 22.2 Percentage of Participants |
| BioThrax | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 11.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 27.8 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 44.14 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 16.7 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 72.2 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 5.6 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 44.4 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 61.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 33.3 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 5.6 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 11.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 11.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 88.9 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 16.7 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 16.7 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 5.6 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 16.7 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 5.6 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 11.1 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 55.6 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 0 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 22.2 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 72.2 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 22.2 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 0 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 1 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 33.3 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 11.8 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 70.6 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 52.9 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 17.6 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 11.8 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 11.8 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 11.8 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 64.7 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 64.7 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 58.8 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 58.8 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 17.6 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 17.6 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 41.2 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 35.3 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 5.9 Percentage of Participants |
| AV7909 Formulation 2 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 15.8 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 10.5 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 10.5 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 15.8 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 21.1 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 15.8 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 10.5 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 10.5 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 10.5 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 57.9 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 42.1 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 10.5 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 5.3 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 5.3 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 31.6 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 52.6 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 31.6 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 10.5 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 42.1 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 42.1 Percentage of Participants |
| AV7909 Formulation 3 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 10.5 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 33.3 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 16.7 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 72.2 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 33.3 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 16.7 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 16.7 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 27.8 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 5.6 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 5.6 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 38.9 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 44.4 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 0 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 66.7 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 16.7 Percentage of Participants |
| AV7909 Formulation 4 | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 50.0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Arm Motion Limitation | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Itching | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Reaction | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Tenderness | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Arm Motion Limitation | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Pain | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Tenderness | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Arm Motion Limitation | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Redness | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Reaction | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Pain | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Redness | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Swelling | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Swelling | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Swelling | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Injection Site Itching | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Arm Motion Limitation | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Reaction | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Tenderness | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Reaction | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Tenderness | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 1 Injection Site Itching | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Swelling | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 3 Injection Site Pain | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Any Redness | 0 Percentage of Participants |
| Saline | Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) | Grade 2 Injection Site Pain | 0 Percentage of Participants |
Primary
Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 0-6
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 55.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 33.3 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 27.8 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 44.4 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reactions | 11.1 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 33.3 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 33.3 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 22.2 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 22.2 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 11.1 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reactions | 38.9 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 27.8 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 5.6 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 22.2 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 33.3 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 50.0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 66.7 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 61.1 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 44.4 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 11.1 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 22.2 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 27.8 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 16.7 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 8.9 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 11.1 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 22.2 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 41.2 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 29.4 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reactions | 11.8 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 17.6 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 11.8 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 17.6 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 11.8 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 29.4 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 17.6 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 11.8 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 11.8 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 11.8 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 10.5 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 5.3 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reactions | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 5.3 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 15.8 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 10.5 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 15.8 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 15.8 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 15.8 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 16.47 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 27.8 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 11.1 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 5.6 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reactions | 22.2 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 38.9 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 11.1 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 11.1 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 11.1 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 11.1 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 11.1 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 11.1 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 5.6 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 5.6 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 22.2 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Nausea / GI Upset | 13.3 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Muscle Ache | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Systemic Reactions | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fatigue | 13.3 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Headache | 13.3 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fatigue | 13.3 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Systemic Reaction | 26.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Nausea / GI Upset | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Headache | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Fever | 13.3 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Nausea / GI Upset | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Headache | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 2 Fatigue | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Fever | 13.3 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Systemic Reaction | 33.3 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Any Muscle Ache | 13.3 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Systemic Reaction | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 1 Muscle Ache | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) | Grade 3 Headache | 0 percentage of participants |
Primary
Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 14-20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 16.7 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 11.1 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 16.7 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 38.9 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 11.1 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 16.7 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 16.7 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 0 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 5.6 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 22.2 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 27.8 percentage of participants |
| BioThrax | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 27.8 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 27.8 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 11.1 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 27.8 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 11.1 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 5.6 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 27.8 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 11.1 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 27.8 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 5.6 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 38.9 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 5.6 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 16.7 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 16.7 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 44.14 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 77.8 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 50.0 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 44.4 percentage of participants |
| AV7909 Formulation 1 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 5.6 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 17.6 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 11.8 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 35.3 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 0 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 23.5 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 41.2 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 17.6 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 17.6 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 5.9 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 17.6 percentage of participants |
| AV7909 Formulation 2 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 5.3 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 5.3 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 21.1 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 10.5 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 10.5 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 15.8 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 10.5 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 10.5 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 5.3 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 15.8 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 10.5 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 5.3 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 0 percentage of participants |
| AV7909 Formulation 3 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 50.0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 38.9 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 16.7 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 22.2 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 16.7 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 38.9 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 16.7 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 22.2 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 5.6 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 5.6 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 0 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 27.8 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 22.2 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 5.6 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 16.7 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 22.2 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 38.9 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 11.1 percentage of participants |
| AV7909 Formulation 4 | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Systemic Reaction | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Fatigue | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Muscle Ache | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Fatigue | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Nausea / GI Upset | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Systemic Reaction | 13.3 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Headache | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Headache | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fatigue | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Muscle Ache | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 3 Muscle Ache | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Systemic Reactions | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Headache | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fatigue | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Muscle Ache | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Fever | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Nausea / GI Upset | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Nausea / GI Upset | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 2 Headache | 6.7 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Any Fever | 0 percentage of participants |
| Saline | Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) | Grade 1 Systemic Reaction | 6.7 percentage of participants |
Secondary
Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.
Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.
Time frame: Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.
Population: Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BioThrax | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 28.0 days |
| AV7909 Formulation 1 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 29.0 days |
| AV7909 Formulation 2 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 28.0 days |
| AV7909 Formulation 3 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 28.5 days |
| AV7909 Formulation 4 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 29.0 days |
| Saline | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 7.0 days |
| Male BioThrax | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 28.0 days |
| Male AV7909 Formulation 1 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 28.0 days |
| Male AV7909 Formulation 2 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 28.0 days |
| Male AV7909 Formulation 3 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 28.0 days |
| Male AV7909 Formulation 4 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 28.0 days |
| Male Saline | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 7.0 days |
| Female BioThrax | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 18.5 days |
| Female AV7909 Formulation 1 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 32.0 days |
| Female AV7909 Formulation 2 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 28.0 days |
| Female AV7909 Formulation 3 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 29.0 days |
| Female AV7909 Formulation 4 | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 35.0 days |
| Female Saline | Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 7.0 days |
Secondary
Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.
Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the lower limit of quantitation (LLOQ) of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.
Time frame: Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.
Population: Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BioThrax | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 0.15 geometric mean titer |
| AV7909 Formulation 1 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 3.40 geometric mean titer |
| AV7909 Formulation 2 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 4.02 geometric mean titer |
| AV7909 Formulation 3 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 2.81 geometric mean titer |
| AV7909 Formulation 4 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 1.93 geometric mean titer |
| Saline | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 0.04 geometric mean titer |
| Male BioThrax | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 0.19 geometric mean titer |
| Male AV7909 Formulation 1 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 3.44 geometric mean titer |
| Male AV7909 Formulation 2 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 4.19 geometric mean titer |
| Male AV7909 Formulation 3 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 2.99 geometric mean titer |
| Male AV7909 Formulation 4 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 2.45 geometric mean titer |
| Male Saline | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 0.03 geometric mean titer |
| Female BioThrax | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 0.11 geometric mean titer |
| Female AV7909 Formulation 1 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 3.35 geometric mean titer |
| Female AV7909 Formulation 2 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 3.87 geometric mean titer |
| Female AV7909 Formulation 3 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 2.68 geometric mean titer |
| Female AV7909 Formulation 4 | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 1.53 geometric mean titer |
| Female Saline | Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 0.06 geometric mean titer |
Secondary
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.
Time frame: Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.
Population: Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BioThrax | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 14 | 0.03 geometric mean titer |
| BioThrax | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 21 | 0.04 geometric mean titer |
| BioThrax | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 56 | 0.09 geometric mean titer |
| BioThrax | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 7 | 0.03 geometric mean titer |
| BioThrax | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 0 | 0.03 geometric mean titer |
| BioThrax | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 84 | 0.05 geometric mean titer |
| BioThrax | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 70 | 0.06 geometric mean titer |
| BioThrax | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 42 | 0.13 geometric mean titer |
| BioThrax | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 35 | 0.15 geometric mean titer |
| BioThrax | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 28 | 0.13 geometric mean titer |
| AV7909 Formulation 1 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 0 | 0.03 geometric mean titer |
| AV7909 Formulation 1 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 14 | 0.03 geometric mean titer |
| AV7909 Formulation 1 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 42 | 2.01 geometric mean titer |
| AV7909 Formulation 1 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 21 | 1.27 geometric mean titer |
| AV7909 Formulation 1 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 7 | 0.03 geometric mean titer |
| AV7909 Formulation 1 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 28 | 3.05 geometric mean titer |
| AV7909 Formulation 1 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 70 | 0.85 geometric mean titer |
| AV7909 Formulation 1 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 56 | 1.18 geometric mean titer |
| AV7909 Formulation 1 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 84 | 0.67 geometric mean titer |
| AV7909 Formulation 1 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 35 | 2.61 geometric mean titer |
| AV7909 Formulation 2 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 70 | 0.91 geometric mean titer |
| AV7909 Formulation 2 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 84 | 0.69 geometric mean titer |
| AV7909 Formulation 2 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 0 | 0.03 geometric mean titer |
| AV7909 Formulation 2 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 7 | 0.03 geometric mean titer |
| AV7909 Formulation 2 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 14 | 0.04 geometric mean titer |
| AV7909 Formulation 2 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 21 | 0.77 geometric mean titer |
| AV7909 Formulation 2 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 28 | 3.85 geometric mean titer |
| AV7909 Formulation 2 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 35 | 2.89 geometric mean titer |
| AV7909 Formulation 2 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 42 | 2.03 geometric mean titer |
| AV7909 Formulation 2 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 56 | 1.52 geometric mean titer |
| AV7909 Formulation 3 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 7 | 0.03 geometric mean titer |
| AV7909 Formulation 3 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 0 | 0.03 geometric mean titer |
| AV7909 Formulation 3 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 70 | 0.71 geometric mean titer |
| AV7909 Formulation 3 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 84 | 0.55 geometric mean titer |
| AV7909 Formulation 3 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 35 | 2.23 geometric mean titer |
| AV7909 Formulation 3 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 21 | 0.90 geometric mean titer |
| AV7909 Formulation 3 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 28 | 2.54 geometric mean titer |
| AV7909 Formulation 3 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 42 | 1.78 geometric mean titer |
| AV7909 Formulation 3 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 14 | 0.04 geometric mean titer |
| AV7909 Formulation 3 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 56 | 1.09 geometric mean titer |
| AV7909 Formulation 4 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 0 | 0.03 geometric mean titer |
| AV7909 Formulation 4 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 28 | 1.73 geometric mean titer |
| AV7909 Formulation 4 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 84 | 0.39 geometric mean titer |
| AV7909 Formulation 4 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 70 | 0.55 geometric mean titer |
| AV7909 Formulation 4 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 7 | 0.03 geometric mean titer |
| AV7909 Formulation 4 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 42 | 1.17 geometric mean titer |
| AV7909 Formulation 4 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 14 | 0.04 geometric mean titer |
| AV7909 Formulation 4 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 56 | 0.76 geometric mean titer |
| AV7909 Formulation 4 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 21 | 0.44 geometric mean titer |
| AV7909 Formulation 4 | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 35 | 1.56 geometric mean titer |
| Saline | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 21 | 0.03 geometric mean titer |
| Saline | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 28 | 0.03 geometric mean titer |
| Saline | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 35 | 0.03 geometric mean titer |
| Saline | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 0 | 0.03 geometric mean titer |
| Saline | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 42 | 0.03 geometric mean titer |
| Saline | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 84 | 0.03 geometric mean titer |
| Saline | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 56 | 0.03 geometric mean titer |
| Saline | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 70 | 0.04 geometric mean titer |
| Saline | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 14 | 0.03 geometric mean titer |
| Saline | TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. | Day 7 | 0.03 geometric mean titer |