Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults (NCT NCT01263691)
NCT ID: NCT01263691
Last Updated: 2024-03-18
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
105 participants
Primary outcome timeframe
Days 0-6
Results posted on
2024-03-18
Participant Flow
Participants were enrolled from 27 December 2010 to 08 March 2012 at three medical centers in the U.S.
All 105 enrolled participants who met inclusion and exclusion criteria were dosed.
Participant milestones
| Measure |
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
|
AV7909 Formulation 1
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL anthrax vaccine adsorbed \[AVA\] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
|
AV7909 Formulation 2
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL anthrax vaccine adsorbed \[AVA\] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
|
AV7909 Formulation 3
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL anthrax vaccine adsorbed \[AVA\] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
|
AV7909 Formulation 4
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL anthrax vaccine adsorbed \[AVA\] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
|
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
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
17
|
19
|
18
|
15
|
|
Overall Study
COMPLETED
|
15
|
18
|
16
|
18
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
AV7909 Formulation 1
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL anthrax vaccine adsorbed \[AVA\] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
|
AV7909 Formulation 2
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL anthrax vaccine adsorbed \[AVA\] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
|
AV7909 Formulation 3
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL anthrax vaccine adsorbed \[AVA\] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
|
AV7909 Formulation 4
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL anthrax vaccine adsorbed \[AVA\] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
|
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
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
100 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 10.31 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 9.15 • n=4 Participants
|
31.4 years
STANDARD_DEVIATION 10.72 • n=21 Participants
|
31.4 years
STANDARD_DEVIATION 8.61 • n=10 Participants
|
32.0 years
STANDARD_DEVIATION 9.64 • n=115 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
51 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
54 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
80 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
87 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
17 participants
n=5 Participants
|
19 participants
n=4 Participants
|
18 participants
n=21 Participants
|
15 participants
n=10 Participants
|
105 participants
n=115 Participants
|
|
Weight
|
80.06 kilograms
STANDARD_DEVIATION 18.799 • n=5 Participants
|
83.99 kilograms
STANDARD_DEVIATION 16.137 • n=7 Participants
|
75.75 kilograms
STANDARD_DEVIATION 12.232 • n=5 Participants
|
78.39 kilograms
STANDARD_DEVIATION 19.021 • n=4 Participants
|
76.24 kilograms
STANDARD_DEVIATION 15.649 • n=21 Participants
|
79.74 kilograms
STANDARD_DEVIATION 23.140 • n=10 Participants
|
79.03 kilograms
STANDARD_DEVIATION 17.487 • n=115 Participants
|
PRIMARY outcome
Timeframe: Days 0-6Subjects 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
Outcome measures
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
13 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
8 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
17 Participants
|
13 Participants
|
12 Participants
|
16 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
9 Participants
|
11 Participants
|
6 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
6 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
16 Participants
|
11 Participants
|
11 Participants
|
13 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
13 Participants
|
10 Participants
|
10 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
14 Participants
|
12 Participants
|
8 Participants
|
11 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
12 Participants
|
12 Participants
|
7 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 0-6Subjects 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
Outcome measures
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
94.4 Percentage of Participants
|
76.5 Percentage of Participants
|
63.2 Percentage of Participants
|
88.9 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
50.0 Percentage of Participants
|
64.7 Percentage of Participants
|
31.6 Percentage of Participants
|
61.1 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
33.3 Percentage of Participants
|
11.8 Percentage of Participants
|
31.6 Percentage of Participants
|
27.8 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 Percentage of Participants
|
5.9 Percentage of Participants
|
10.5 Percentage of Participants
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 Percentage of Participants
|
5.9 Percentage of Participants
|
10.5 Percentage of Participants
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
22.2 Percentage of Participants
|
5.9 Percentage of Participants
|
5.3 Percentage of Participants
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Percentage of Participants
|
5.9 Percentage of Participants
|
0 Percentage of Participants
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
5.3 Percentage of Participants
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
88.9 Percentage of Participants
|
64.7 Percentage of Participants
|
57.9 Percentage of Participants
|
72.2 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
72.2 Percentage of Participants
|
58.8 Percentage of Participants
|
52.6 Percentage of Participants
|
61.1 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
16.7 Percentage of Participants
|
5.9 Percentage of Participants
|
5.3 Percentage of Participants
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
77.8 Percentage of Participants
|
70.6 Percentage of Participants
|
42.1 Percentage of Participants
|
61.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
66.7 Percentage of Participants
|
70.6 Percentage of Participants
|
36.8 Percentage of Participants
|
44.4 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
5.3 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 Percentage of Participants
|
11.8 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 Percentage of Participants
|
11.8 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
44.4 Percentage of Participants
|
41.2 Percentage of Participants
|
21.1 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
72.2 Percentage of Participants
|
47.1 Percentage of Participants
|
47.4 Percentage of Participants
|
55.6 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
27.8 Percentage of Participants
|
5.9 Percentage of Participants
|
26.3 Percentage of Participants
|
22.2 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 14-20Subjects 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
Outcome measures
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
13 Participants
|
11 Participants
|
10 Participants
|
12 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
16 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
8 Participants
|
9 Participants
|
6 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
6 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
8 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
13 Participants
|
10 Participants
|
8 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
10 Participants
|
10 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
6 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
4 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 14-20Subjects 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
Outcome measures
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
88.9 Percentage of Participants
|
70.6 Percentage of Participants
|
57.9 Percentage of Participants
|
72.2 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
16.7 Percentage of Participants
|
11.8 Percentage of Participants
|
10.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
61.1 Percentage of Participants
|
41.2 Percentage of Participants
|
42.1 Percentage of Participants
|
44.4 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
44.4 Percentage of Participants
|
52.9 Percentage of Participants
|
31.6 Percentage of Participants
|
38.9 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
33.3 Percentage of Participants
|
17.6 Percentage of Participants
|
15.8 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
10.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
16.7 Percentage of Participants
|
11.8 Percentage of Participants
|
15.8 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
16.7 Percentage of Participants
|
11.8 Percentage of Participants
|
10.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Percentage of Participants
|
0 Percentage of Participants
|
5.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
22.2 Percentage of Participants
|
11.8 Percentage of Participants
|
10.5 Percentage of Participants
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
33.3 Percentage of Participants
|
35.3 Percentage of Participants
|
21.1 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
22.2 Percentage of Participants
|
5.9 Percentage of Participants
|
15.8 Percentage of Participants
|
27.8 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
5.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
72.2 Percentage of Participants
|
64.7 Percentage of Participants
|
52.6 Percentage of Participants
|
66.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
44.14 Percentage of Participants
|
64.7 Percentage of Participants
|
42.1 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
27.8 Percentage of Participants
|
0 Percentage of Participants
|
10.5 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
72.2 Percentage of Participants
|
58.8 Percentage of Participants
|
42.1 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
55.6 Percentage of Participants
|
58.8 Percentage of Participants
|
31.6 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
10.5 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
16.7 Percentage of Participants
|
17.6 Percentage of Participants
|
10.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 Percentage of Participants
|
17.6 Percentage of Participants
|
10.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 0-6Subjects 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
Outcome measures
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
9 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
12 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
7 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
8 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
6 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
7 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 0-6Subjects 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
Outcome measures
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
33.3 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
22.2 percentage of participants
|
17.6 percentage of participants
|
5.3 percentage of participants
|
5.6 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
8.9 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
16.47 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
22.2 percentage of participants
|
11.8 percentage of participants
|
10.5 percentage of participants
|
11.1 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 percentage of participants
|
11.8 percentage of participants
|
10.5 percentage of participants
|
11.1 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
66.7 percentage of participants
|
41.2 percentage of participants
|
15.8 percentage of participants
|
38.9 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
27.8 percentage of participants
|
29.4 percentage of participants
|
15.8 percentage of participants
|
11.1 percentage of participants
|
26.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
38.9 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
22.2 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
50.0 percentage of participants
|
17.6 percentage of participants
|
15.8 percentage of participants
|
22.2 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
22.2 percentage of participants
|
5.9 percentage of participants
|
15.8 percentage of participants
|
11.1 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
27.8 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
44.4 percentage of participants
|
17.6 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
61.1 percentage of participants
|
29.4 percentage of participants
|
5.3 percentage of participants
|
27.8 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 14-20Subjects 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
Outcome measures
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
3 participants
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
14 participants
|
7 participants
|
4 participants
|
9 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
8 participants
|
6 participants
|
2 participants
|
4 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5 participants
|
1 participants
|
2 participants
|
5 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
8 participants
|
4 participants
|
3 participants
|
7 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5 participants
|
3 participants
|
1 participants
|
4 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 participants
|
1 participants
|
2 participants
|
3 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
9 participants
|
3 participants
|
2 participants
|
7 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5 participants
|
2 participants
|
1 participants
|
4 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
3 participants
|
1 participants
|
1 participants
|
3 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
7 participants
|
3 participants
|
3 participants
|
7 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5 participants
|
3 participants
|
2 participants
|
3 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 participants
|
0 participants
|
1 participants
|
4 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 14-20Subjects 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
Outcome measures
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
44.14 percentage of participants
|
35.3 percentage of participants
|
10.5 percentage of participants
|
22.2 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
27.8 percentage of participants
|
5.9 percentage of participants
|
10.5 percentage of participants
|
27.8 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
38.9 percentage of participants
|
17.6 percentage of participants
|
15.8 percentage of participants
|
38.9 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
77.8 percentage of participants
|
41.2 percentage of participants
|
21.1 percentage of participants
|
50.0 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
44.4 percentage of participants
|
23.5 percentage of participants
|
15.8 percentage of participants
|
38.9 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
27.8 percentage of participants
|
17.6 percentage of participants
|
5.3 percentage of participants
|
22.2 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 percentage of participants
|
5.9 percentage of participants
|
10.5 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
50.0 percentage of participants
|
17.6 percentage of participants
|
10.5 percentage of participants
|
38.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
27.8 percentage of participants
|
11.8 percentage of participants
|
5.3 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
16.7 percentage of participants
|
5.9 percentage of participants
|
5.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
27.8 percentage of participants
|
17.6 percentage of participants
|
10.5 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 percentage of participants
|
0 percentage of participants
|
5.3 percentage of participants
|
22.2 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 0-56Hematology 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.
Outcome measures
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Alanine aminotransferase increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Blood urea increased
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
White blood cell count increased
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Aspartate aminotransferase increased
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Blood creatinine increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Blood lactate dehydrogenase increased
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hepatic enzyme increased
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hyperkalemia
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hypoglycemia
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hypokalemia
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hypomagnesemia
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Lymphocyte count decreased
|
0 participants
|
6 participants
|
3 participants
|
1 participants
|
4 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Neutropenia
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Neutrophil count decreased
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Protein urine
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Red blood cells urine positive
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
White blood cell count decreased
|
2 participants
|
5 participants
|
4 participants
|
0 participants
|
2 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
White blood cells urine positive
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 0-56Hematology 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.
Outcome measures
| Measure |
BioThrax
n=18 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 Participants
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
|
AV7909 Formulation 2
n=17 Participants
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
|
AV7909 Formulation 3
n=19 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hypokalemia
|
0 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
5.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Alanine aminotransferase increased
|
0 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hepatic enzyme increased
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hyperkalemia
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hypoglycemia
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
10.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Neutropenia
|
5.6 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Protein urine
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
5.3 percentage of participants
|
5.6 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Aspartate aminotransferase increased
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Blood creatinine increased
|
0 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Blood lactate dehydrogenase increased
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Blood urea increased
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hypomagnesemia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Lymphocyte count decreased
|
0 percentage of participants
|
33.3 percentage of participants
|
17.6 percentage of participants
|
5.3 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Neutrophil count decreased
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Red blood cells urine positive
|
0 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
White blood cell count decreased
|
11.1 percentage of participants
|
27.8 percentage of participants
|
23.5 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
White blood cell count increased
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
White blood cells urine positive
|
0 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
BioThrax
n=16 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=17 Participants
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
|
AV7909 Formulation 2
n=16 Participants
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
|
AV7909 Formulation 3
n=18 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
n=8 Participants
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
n=9 Participants
Male 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 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).
|
Male AV7909 Formulation 2
n=8 Participants
Male 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 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).
|
Male AV7909 Formulation 3
n=8 Participants
Male 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 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).
|
Male AV7909 Formulation 4
n=9 Participants
Male 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 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).
|
Male Saline
n=7 Participants
Male Participants between 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).
|
Female BioThrax
n=8 Participants
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
n=8 Participants
Female 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 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).
|
Female AV7909 Formulation 2
n=8 Participants
Female 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 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).
|
Female AV7909 Formulation 3
n=10 Participants
Female 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 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).
|
Female AV7909 Formulation 4
n=9 Participants
Female 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 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).
|
Female Saline
n=8 Participants
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
Interval 0.07 to 0.3
|
3.40 geometric mean titer
Interval 2.33 to 4.94
|
4.02 geometric mean titer
Interval 2.46 to 6.57
|
2.81 geometric mean titer
Interval 1.5 to 5.26
|
1.93 geometric mean titer
Interval 0.85 to 4.43
|
0.04 geometric mean titer
Interval 0.02 to 0.08
|
0.19 geometric mean titer
Interval 0.06 to 0.62
|
3.44 geometric mean titer
Interval 1.84 to 6.43
|
4.19 geometric mean titer
Interval 2.19 to 7.98
|
2.99 geometric mean titer
Interval 1.32 to 6.78
|
2.45 geometric mean titer
Interval 0.54 to 11.12
|
0.03 geometric mean titer
All values were equal and below the lower limit of quantitation
|
0.11 geometric mean titer
Interval 0.04 to 0.36
|
3.35 geometric mean titer
Interval 1.91 to 5.88
|
3.87 geometric mean titer
Interval 1.54 to 9.71
|
2.68 geometric mean titer
Interval 0.92 to 7.8
|
1.53 geometric mean titer
Interval 0.53 to 4.39
|
0.06 geometric mean titer
Interval 0.01 to 0.21
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
BioThrax
n=16 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=17 Participants
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
|
AV7909 Formulation 2
n=16 Participants
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
|
AV7909 Formulation 3
n=18 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
n=8 Participants
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
n=9 Participants
Male 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 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).
|
Male AV7909 Formulation 2
n=8 Participants
Male 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 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).
|
Male AV7909 Formulation 3
n=8 Participants
Male 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 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).
|
Male AV7909 Formulation 4
n=9 Participants
Male 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 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).
|
Male Saline
n=7 Participants
Male Participants between 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).
|
Female BioThrax
n=8 Participants
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
n=8 Participants
Female 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 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).
|
Female AV7909 Formulation 2
n=8 Participants
Female 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 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).
|
Female AV7909 Formulation 3
n=10 Participants
Female 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 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).
|
Female AV7909 Formulation 4
n=9 Participants
Female 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 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).
|
Female Saline
n=8 Participants
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
Interval 7.0 to 42.0
|
29.0 days
Interval 21.0 to 42.0
|
28.0 days
Interval 22.0 to 35.0
|
28.5 days
Interval 27.0 to 42.0
|
29.0 days
Interval 7.0 to 42.0
|
7.0 days
Interval 6.0 to 70.0
|
28.0 days
Interval 7.0 to 35.0
|
28.0 days
Interval 21.0 to 42.0
|
28.0 days
Interval 22.0 to 35.0
|
28.0 days
Interval 28.0 to 39.0
|
28.0 days
Interval 7.0 to 35.0
|
7.0 days
Interval 7.0 to 8.0
|
18.5 days
Interval 7.0 to 42.0
|
32.0 days
Interval 28.0 to 36.0
|
28.0 days
Interval 22.0 to 30.0
|
29.0 days
Interval 27.0 to 42.0
|
35.0 days
Interval 21.0 to 42.0
|
7.0 days
Interval 6.0 to 70.0
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
BioThrax
n=16 Participants
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=17 Participants
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
|
AV7909 Formulation 2
n=16 Participants
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
|
AV7909 Formulation 3
n=18 Participants
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
|
AV7909 Formulation 4
n=18 Participants
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
|
Saline
n=15 Participants
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
Male BioThrax
Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Male AV7909 Formulation 1
Male 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 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).
|
Male AV7909 Formulation 2
Male 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 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).
|
Male AV7909 Formulation 3
Male 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 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).
|
Male AV7909 Formulation 4
Male 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 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).
|
Male Saline
Male Participants between 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).
|
Female BioThrax
Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (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).
|
Female AV7909 Formulation 1
Female 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 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).
|
Female AV7909 Formulation 2
Female 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 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).
|
Female AV7909 Formulation 3
Female 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 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).
|
Female AV7909 Formulation 4
Female 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 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).
|
Female Saline
Female Participants between 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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Day 28
|
0.13 geometric mean titer
Interval 0.06 to 0.28
|
3.05 geometric mean titer
Interval 2.07 to 4.52
|
3.85 geometric mean titer
Interval 2.4 to 6.2
|
2.54 geometric mean titer
Interval 1.26 to 5.12
|
1.73 geometric mean titer
Interval 0.77 to 3.89
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Day 0
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Day 14
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.04 geometric mean titer
Interval 0.03 to 0.05
|
0.04 geometric mean titer
Interval 0.03 to 0.06
|
0.04 geometric mean titer
Interval 0.03 to 0.05
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Day 56
|
0.09 geometric mean titer
Interval 0.05 to 0.16
|
1.18 geometric mean titer
Interval 0.81 to 1.71
|
1.52 geometric mean titer
Interval 0.97 to 2.36
|
1.09 geometric mean titer
Interval 0.58 to 2.07
|
0.76 geometric mean titer
Interval 0.37 to 1.61
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Day 84
|
0.05 geometric mean titer
Interval 0.04 to 0.08
|
0.67 geometric mean titer
Interval 0.42 to 1.08
|
0.69 geometric mean titer
Interval 0.44 to 1.1
|
0.55 geometric mean titer
Interval 0.32 to 0.94
|
0.39 geometric mean titer
Interval 0.2 to 0.77
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Day 7
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Day 21
|
0.04 geometric mean titer
Interval 0.0276 to 0.0651
|
1.27 geometric mean titer
Interval 0.78 to 2.07
|
0.77 geometric mean titer
Interval 0.32 to 1.83
|
0.90 geometric mean titer
Interval 0.46 to 1.75
|
0.44 geometric mean titer
Interval 0.17 to 1.1
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Day 35
|
0.15 geometric mean titer
Interval 0.07 to 0.32
|
2.61 geometric mean titer
Interval 1.82 to 3.75
|
2.89 geometric mean titer
Interval 1.8 to 4.61
|
2.23 geometric mean titer
Interval 1.11 to 4.45
|
1.56 geometric mean titer
Interval 0.68 to 3.59
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Day 42
|
0.13 geometric mean titer
Interval 0.07 to 0.24
|
2.01 geometric mean titer
Interval 1.37 to 2.95
|
2.03 geometric mean titer
Interval 1.32 to 3.12
|
1.78 geometric mean titer
Interval 0.95 to 3.34
|
1.17 geometric mean titer
Interval 0.53 to 2.59
|
0.03 geometric mean titer
All values were below the LLOQ for the assay
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Day 70
|
0.06 geometric mean titer
Interval 0.04 to 0.1
|
0.85 geometric mean titer
Interval 0.56 to 1.29
|
0.91 geometric mean titer
Interval 0.58 to 1.41
|
0.71 geometric mean titer
Interval 0.4 to 1.25
|
0.55 geometric mean titer
Interval 0.26 to 1.16
|
0.04 geometric mean titer
Interval 0.02 to 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
BioThrax
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
AV7909 Formulation 1
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
AV7909 Formulation 2
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
AV7909 Formulation 3
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
AV7909 Formulation 4
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Saline
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BioThrax
n=18 participants at risk
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 participants at risk
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
|
AV7909 Formulation 2
n=17 participants at risk
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
|
AV7909 Formulation 3
n=19 participants at risk
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
|
AV7909 Formulation 4
n=18 participants at risk
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
|
Saline
n=15 participants at risk
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
|---|---|---|---|---|---|---|
|
Investigations
Elevated hepatic enzymes
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
6.7%
1/15 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.9%
1/17 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Social circumstances
Death
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
Other adverse events
| Measure |
BioThrax
n=18 participants at risk
Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
|
AV7909 Formulation 1
n=18 participants at risk
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
|
AV7909 Formulation 2
n=17 participants at risk
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
|
AV7909 Formulation 3
n=19 participants at risk
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
|
AV7909 Formulation 4
n=18 participants at risk
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
|
Saline
n=15 participants at risk
Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
44.4%
8/18 • Number of events 13 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
72.2%
13/18 • Number of events 21 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
35.3%
6/17 • Number of events 14 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
21.1%
4/19 • Number of events 6 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
50.0%
9/18 • Number of events 13 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
20.0%
3/15 • Number of events 4 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Nervous system disorders
Headache
|
33.3%
6/18 • Number of events 15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
61.1%
11/18 • Number of events 20 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
29.4%
5/17 • Number of events 9 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
26.3%
5/19 • Number of events 5 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
55.6%
10/18 • Number of events 17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
13.3%
2/15 • Number of events 6 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
General disorders
Injection Site Reaction
|
83.3%
15/18 • Number of events 27 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
100.0%
18/18 • Number of events 36 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
82.4%
14/17 • Number of events 27 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
73.7%
14/19 • Number of events 24 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
88.9%
16/18 • Number of events 32 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
13.3%
2/15 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
33.3%
6/18 • Number of events 6 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
17.6%
3/17 • Number of events 3 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.3%
1/19 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
22.2%
4/18 • Number of events 4 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
44.4%
8/18 • Number of events 12 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
55.6%
10/18 • Number of events 21 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
23.5%
4/17 • Number of events 11 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
10.5%
2/19 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
55.6%
10/18 • Number of events 14 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
13.3%
2/15 • Number of events 3 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
33.3%
6/18 • Number of events 14 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
17.6%
3/17 • Number of events 3 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
10.5%
2/19 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
22.2%
4/18 • Number of events 5 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
6.7%
1/15 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
11.1%
2/18 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
17.6%
3/17 • Number of events 3 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.3%
1/19 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
16.7%
3/18 • Number of events 3 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
13.3%
2/15 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
27.8%
5/18 • Number of events 7 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
17.6%
3/17 • Number of events 6 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.3%
1/19 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
11.1%
2/18 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
13.3%
2/15 • Number of events 3 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
White Blood Cell Count Decreased
|
11.1%
2/18 • Number of events 3 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
27.8%
5/18 • Number of events 5 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
23.5%
4/17 • Number of events 5 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
11.1%
2/18 • Number of events 3 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
6.7%
1/15 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Injury, poisoning and procedural complications
Jaw Fracture
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Injury, poisoning and procedural complications
Traumatic Lung Injury
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.9%
1/17 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
6.7%
1/15 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
11.1%
2/18 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Blood creatine increased
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.9%
1/17 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
6.7%
1/15 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Blood urea increased
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
6.7%
1/15 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Hyperkalemia
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Hypoglycemia
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
10.5%
2/19 • Number of events 2 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Hypokalemia
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.9%
1/17 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.3%
1/19 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Hypomagnesemia
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.3%
1/19 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Neutropenia
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Protein urine
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.3%
1/19 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
6.7%
1/15 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.9%
1/17 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
White blood cell count increased
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.6%
1/18 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/17 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
5.9%
1/17 • Number of events 1 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/19 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/18 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
0.00%
0/15 • Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0. Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol. For determination of Other Adverse Events frequency, all study Arms were combined.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor is responsible for public disclosure of study data. Any proposed publication is subject to review agreed between National Institute of Allergy and Infectious Disease (NIAID) and Emergent; between Emergent and the contract research organizations (CROs)/vendors; and between the CROs and the site Principal Investigator. Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, but data and publication thereof will not be unduly withheld.
- Publication restrictions are in place
Restriction type: OTHER