Trial Outcomes & Findings for Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule (NCT NCT01641991)
NCT ID: NCT01641991
Last Updated: 2014-05-28
Results Overview
Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. A participant met the threshold of a 4-fold rise in NF50 antibody titer if the post vaccination titer was an increase by 4-fold or more from the baseline (Day 0) titer.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
328 participants
Primary outcome timeframe
Days 0, 7, 14, 21, 28 35, 42, 49, 56, 63, 70, 84 and 100
Results posted on
2014-05-28
Participant Flow
Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled and vaccinated between 05JUL2012 and 30NOV2012.
Participant milestones
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
82
|
82
|
|
Overall Study
COMPLETED
|
73
|
74
|
65
|
66
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
17
|
16
|
Reasons for withdrawal
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
1
|
5
|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
3
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
0
|
|
Overall Study
no longer eligible
|
2
|
1
|
0
|
4
|
Baseline Characteristics
Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule
Baseline characteristics by cohort
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=82 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=82 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=82 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=82 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.0 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
34.6 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
35.7 years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
|
Age, Categorical
<=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
328 Participants
n=21 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
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
166 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
162 Participants
n=21 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
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
245 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
309 Participants
n=21 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
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
82 participants
n=7 Participants
|
82 participants
n=5 Participants
|
82 participants
n=4 Participants
|
328 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Days 0, 7, 14, 21, 28 35, 42, 49, 56, 63, 70, 84 and 100Population: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.
Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. A participant met the threshold of a 4-fold rise in NF50 antibody titer if the post vaccination titer was an increase by 4-fold or more from the baseline (Day 0) titer.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=60 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 7
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 14
|
4 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 21
|
26 participants
|
12 participants
|
19 participants
|
12 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 28
|
63 participants
|
13 participants
|
56 participants
|
46 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 35
|
65 participants
|
32 participants
|
59 participants
|
53 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 42
|
63 participants
|
59 participants
|
59 participants
|
58 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 49
|
63 participants
|
59 participants
|
59 participants
|
56 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 56
|
59 participants
|
59 participants
|
59 participants
|
55 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 63
|
57 participants
|
59 participants
|
59 participants
|
54 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 70
|
56 participants
|
59 participants
|
59 participants
|
54 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 84
|
44 participants
|
58 participants
|
58 participants
|
51 participants
|
|
Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer
Day 100
|
34 participants
|
54 participants
|
56 participants
|
44 participants
|
SECONDARY outcome
Timeframe: Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.Population: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.
Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (4.64) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=60 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 14
|
6.16 µg/mL
Interval 4.84 to 7.83
|
5.48 µg/mL
Interval 4.85 to 6.18
|
5.28 µg/mL
Interval 4.8 to 5.79
|
5.01 µg/mL
Interval 4.61 to 5.43
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 0
|
4.64 µg/mL
no variability among the subjects' concentrations
|
4.64 µg/mL
no variability among the subjects' concentrations
|
4.64 µg/mL
no variability among the subjects' concentrations
|
4.64 µg/mL
no variability among the subjects' concentrations
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 7
|
5.01 µg/mL
Interval 4.29 to 5.84
|
4.71 µg/mL
Interval 4.56 to 4.86
|
4.91 µg/mL
Interval 4.38 to 5.5
|
4.70 µg/mL
Interval 4.57 to 4.82
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 21
|
13.67 µg/mL
Interval 10.08 to 18.54
|
7.62 µg/mL
Interval 6.18 to 9.41
|
12.11 µg/mL
Interval 9.47 to 15.49
|
7.63 µg/mL
Interval 6.17 to 9.44
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 28
|
88.43 µg/mL
Interval 69.73 to 112.14
|
7.62 µg/mL
Interval 6.22 to 9.33
|
84.05 µg/mL
Interval 67.77 to 104.23
|
52.13 µg/mL
Interval 37.8 to 71.9
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 35
|
89.44 µg/mL
Interval 72.41 to 110.48
|
17.16 µg/mL
Interval 12.34 to 23.87
|
154.49 µg/mL
Interval 125.63 to 189.98
|
86.74 µg/mL
Interval 64.13 to 117.32
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 42
|
76.32 µg/mL
Interval 61.94 to 94.04
|
253.53 µg/mL
Interval 202.43 to 317.52
|
170.40 µg/mL
Interval 140.82 to 206.19
|
108.26 µg/mL
Interval 83.05 to 141.11
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 49
|
61.77 µg/mL
Interval 49.87 to 76.5
|
201.87 µg/mL
Interval 162.54 to 250.73
|
141.93 µg/mL
Interval 117.95 to 170.79
|
93.07 µg/mL
Interval 72.01 to 120.3
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 56
|
52.95 µg/mL
Interval 42.16 to 66.49
|
158.13 µg/mL
Interval 128.27 to 194.95
|
119.28 µg/mL
Interval 98.72 to 144.11
|
77.77 µg/mL
Interval 59.87 to 101.02
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 63
|
41.87 µg/mL
Interval 33.34 to 52.57
|
128.92 µg/mL
Interval 104.68 to 158.76
|
99.20 µg/mL
Interval 82.32 to 119.54
|
66.54 µg/mL
Interval 51.51 to 85.96
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 70
|
36.32 µg/mL
Interval 28.95 to 45.58
|
105.14 µg/mL
Interval 84.81 to 130.35
|
87.13 µg/mL
Interval 72.35 to 104.93
|
56.48 µg/mL
Interval 43.74 to 72.93
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 84
|
25.75 µg/mL
Interval 20.36 to 32.58
|
70.14 µg/mL
Interval 55.63 to 88.44
|
65.42 µg/mL
Interval 54.36 to 78.73
|
43.30 µg/mL
Interval 33.85 to 55.38
|
|
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
Day 100
|
19.38 µg/mL
Interval 15.24 to 24.64
|
51.22 µg/mL
Interval 41.48 to 63.23
|
48.77 µg/mL
Interval 40.58 to 58.6
|
32.53 µg/mL
Interval 25.41 to 41.65
|
SECONDARY outcome
Timeframe: Days 0-7 after vaccination at Day 0Population: The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.
Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=68 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=67 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Pain at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Pain at injection site, moderate
|
17 participants
|
12 participants
|
12 participants
|
8 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Pain at injection site, mild
|
29 participants
|
41 participants
|
42 participants
|
35 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Itchiness at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Itchiness at injection site, moderate
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Itchiness at injection site, mild
|
11 participants
|
12 participants
|
7 participants
|
10 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Warmth at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Warmth at injection site, moderate
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Warmth at injection site, mild
|
31 participants
|
25 participants
|
28 participants
|
21 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Tenderness at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Tenderness at injection site, moderate
|
22 participants
|
15 participants
|
18 participants
|
10 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Tenderness at injection site, mild
|
38 participants
|
44 participants
|
45 participants
|
42 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Arm motion limitations, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Arm motion limitations, moderate
|
3 participants
|
4 participants
|
9 participants
|
6 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Arm motion limitations, mild
|
14 participants
|
13 participants
|
15 participants
|
10 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Erythema, severe
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Erythema, moderate
|
5 participants
|
4 participants
|
5 participants
|
3 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Erythema, mild
|
26 participants
|
23 participants
|
21 participants
|
17 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Edema, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Edema, moderate
|
4 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
Edema, mild
|
16 participants
|
17 participants
|
17 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Days 0-7 after vaccination at Day 14Population: The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.
Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=65 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=65 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=65 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Pain at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Pain at injection site, moderate
|
13 participants
|
12 participants
|
4 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Pain at injection site, mild
|
32 participants
|
37 participants
|
35 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Itchiness at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Itchiness at injection site, moderate
|
6 participants
|
6 participants
|
3 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Itchiness at injection site, mild
|
26 participants
|
21 participants
|
22 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Warmth at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Warmth at injection site, moderate
|
4 participants
|
2 participants
|
2 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Warmth at injection site, mild
|
30 participants
|
31 participants
|
27 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Tenderness at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Tenderness at injection site, moderate
|
24 participants
|
16 participants
|
14 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Tenderness at injection site, mild
|
34 participants
|
43 participants
|
43 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Arm motion limitations, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Arm motion limitations, moderate
|
7 participants
|
2 participants
|
4 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Arm motion limitations, mild
|
21 participants
|
20 participants
|
7 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Erythema, severe
|
1 participants
|
3 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Erythema, moderate
|
13 participants
|
11 participants
|
9 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Erythema, mild
|
19 participants
|
12 participants
|
15 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Edema, severe
|
1 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Edema, moderate
|
10 participants
|
7 participants
|
5 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
Edema, mild
|
17 participants
|
18 participants
|
11 participants
|
—
|
SECONDARY outcome
Timeframe: Days 0-7 after vaccination at Day 28Population: The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.
Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=64 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=61 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=61 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Pain at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Pain at injection site, moderate
|
11 participants
|
3 participants
|
2 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Pain at injection site, mild
|
37 participants
|
24 participants
|
17 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Itchiness at injection site, severe
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Itchiness at injection site, moderate
|
6 participants
|
3 participants
|
4 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Itchiness at injection site, mild
|
21 participants
|
18 participants
|
24 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Warmth at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Warmth at injection site, moderate
|
4 participants
|
2 participants
|
1 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Warmth at injection site, mild
|
26 participants
|
30 participants
|
27 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Tenderness at injection site, severe
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Tenderness at injection site, moderate
|
15 participants
|
3 participants
|
4 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Tenderness at injection site, mild
|
44 participants
|
43 participants
|
43 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Arm motion limitations, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Arm motion limitations, moderate
|
3 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Arm motion limitations, mild
|
16 participants
|
7 participants
|
5 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Erythema, severe
|
0 participants
|
1 participants
|
1 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Erythema, moderate
|
17 participants
|
6 participants
|
7 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Erythema, mild
|
14 participants
|
15 participants
|
17 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Edema, severe
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Edema, moderate
|
5 participants
|
2 participants
|
5 participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
Edema, mild
|
20 participants
|
13 participants
|
15 participants
|
—
|
SECONDARY outcome
Timeframe: Days 0-7 after vaccination at Month 6Population: The analysis population includes all participants who received the 6-month booster vaccination.
Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=60 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=60 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=56 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=56 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Pain at injection site, severe
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Pain at injection site, moderate
|
20 participants
|
9 participants
|
10 participants
|
13 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Pain at injection site, mild
|
24 participants
|
29 participants
|
27 participants
|
20 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Itchiness at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Itchiness at injection site, moderate
|
4 participants
|
2 participants
|
3 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Itchiness at injection site, mild
|
10 participants
|
9 participants
|
6 participants
|
6 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Warmth at injection site, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Warmth at injection site, moderate
|
0 participants
|
2 participants
|
4 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Warmth at injection site, mild
|
17 participants
|
17 participants
|
15 participants
|
18 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Tenderness at injection site, severe
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Tenderness at injection site, moderate
|
16 participants
|
9 participants
|
15 participants
|
14 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Tenderness at injection site, mild
|
33 participants
|
42 participants
|
28 participants
|
30 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Arm motion limitations, severe
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Arm motion limitations, moderate
|
7 participants
|
6 participants
|
7 participants
|
9 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Arm motion limitations, mild
|
16 participants
|
8 participants
|
14 participants
|
13 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Erythema, severe
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Erythema, moderate
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Erythema, mild
|
4 participants
|
1 participants
|
5 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Edema, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Edema, moderate
|
3 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
Edema, mild
|
5 participants
|
2 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Days 0-7 after each vaccinationPopulation: The analysis population includes all participants who were vaccinated per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.
Participants were given a ruler with the memory aid to measure the occurrence of edema (swelling) and erythema (redness) daily for at least 8 days after each vaccination. Participants are counted in this outcome measure if they had measurements of greater than 120 mm in the 8-day period after at least one vaccination, first separately for edema and erythema, and in the last category, edema and/or erythema, if they had either or both reactions of greater than 120 mm.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=68 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=67 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm)
Erythema
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm)
Edema
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm)
Edema and/or Erythema
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.Population: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.
Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (0.03) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=60 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 0
|
0.03 titer
no variability among the subjects' titers
|
0.03 titer
no variability among the subjects' titers
|
0.03 titer
no variability among the subjects' titers
|
0.03 titer
no variability among the subjects' titers
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 7
|
0.03 titer
Interval 0.03 to 0.04
|
0.03 titer
no variability among the subjects' titers
|
0.03 titer
Interval 0.03 to 0.04
|
0.03 titer
no variability among the subjects' titers
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 14
|
0.04 titer
Interval 0.03 to 0.05
|
0.04 titer
Interval 0.03 to 0.04
|
0.04 titer
Interval 0.03 to 0.04
|
0.03 titer
Interval 0.03 to 0.03
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 21
|
0.10 titer
Interval 0.07 to 0.13
|
0.06 titer
Interval 0.04 to 0.08
|
0.08 titer
Interval 0.06 to 0.11
|
0.05 titer
Interval 0.04 to 0.07
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 28
|
0.62 titer
Interval 0.48 to 0.8
|
0.06 titer
Interval 0.05 to 0.08
|
0.65 titer
Interval 0.5 to 0.85
|
0.38 titer
Interval 0.26 to 0.55
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 35
|
0.61 titer
Interval 0.49 to 0.76
|
0.17 titer
Interval 0.12 to 0.24
|
1.22 titer
Interval 0.98 to 1.51
|
0.75 titer
Interval 0.55 to 1.02
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 42
|
0.51 titer
Interval 0.41 to 0.63
|
2.85 titer
Interval 2.21 to 3.67
|
1.33 titer
Interval 1.09 to 1.62
|
0.91 titer
Interval 0.7 to 1.18
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 49
|
0.41 titer
Interval 0.33 to 0.5
|
2.19 titer
Interval 1.74 to 2.76
|
1.02 titer
Interval 0.84 to 1.24
|
0.74 titer
Interval 0.57 to 0.98
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 56
|
0.35 titer
Interval 0.28 to 0.44
|
1.62 titer
Interval 1.28 to 2.04
|
0.83 titer
Interval 0.68 to 1.02
|
0.61 titer
Interval 0.47 to 0.8
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 63
|
0.27 titer
Interval 0.21 to 0.33
|
1.27 titer
Interval 1.0 to 1.62
|
0.71 titer
Interval 0.58 to 0.86
|
0.51 titer
Interval 0.39 to 0.67
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 70
|
0.24 titer
Interval 0.19 to 0.29
|
1.00 titer
Interval 0.79 to 1.26
|
0.60 titer
Interval 0.49 to 0.73
|
0.44 titer
Interval 0.34 to 0.57
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 84
|
0.17 titer
Interval 0.13 to 0.21
|
0.64 titer
Interval 0.51 to 0.81
|
0.45 titer
Interval 0.37 to 0.54
|
0.30 titer
Interval 0.23 to 0.39
|
|
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
Day 100
|
0.13 titer
Interval 0.1 to 0.16
|
0.44 titer
Interval 0.35 to 0.55
|
0.34 titer
Interval 0.28 to 0.41
|
0.24 titer
Interval 0.18 to 0.3
|
SECONDARY outcome
Timeframe: Day 7 through Day 100Population: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.
Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. To determine the group peak GMC, the highest antibody concentration assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of subjects' peak concentrations was calculated along with the 95% confidence intervals.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=60 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100
|
102.32 µg/mL
Interval 82.31 to 127.19
|
265.08 µg/mL
Interval 214.11 to 328.18
|
182.42 µg/mL
Interval 150.28 to 221.42
|
114.42 µg/mL
Interval 87.49 to 149.64
|
SECONDARY outcome
Timeframe: Days 0-7 after vaccination at Day 0Population: The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.
Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=68 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=67 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.
Fatigue, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.
Fatigue, moderate
|
6 participants
|
6 participants
|
8 participants
|
3 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.
Fatigue, mild
|
9 participants
|
12 participants
|
12 participants
|
15 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.
Muscle aches, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.
Muscle aches, moderate
|
2 participants
|
2 participants
|
7 participants
|
4 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.
Muscle aches, mild
|
15 participants
|
16 participants
|
12 participants
|
14 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.
Headache, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.
Headache, moderate
|
6 participants
|
3 participants
|
4 participants
|
3 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.
Headache, mild
|
9 participants
|
13 participants
|
15 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Days 0-7 after vaccination at Day 14Population: The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.
Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=65 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=65 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=65 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.
Fatigue, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.
Fatigue, moderate
|
7 participants
|
3 participants
|
5 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.
Fatigue, mild
|
17 participants
|
15 participants
|
10 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.
Muscle aches, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.
Muscle aches, moderate
|
7 participants
|
6 participants
|
3 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.
Muscle aches, mild
|
18 participants
|
13 participants
|
14 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.
Headache, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.
Headache, moderate
|
4 participants
|
4 participants
|
4 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.
Headache, mild
|
14 participants
|
17 participants
|
11 participants
|
—
|
SECONDARY outcome
Timeframe: Days 0-7 after vaccination at Day 28Population: The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.
Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=64 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=61 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=61 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.
Fatigue, severe
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.
Fatigue, moderate
|
2 participants
|
2 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.
Fatigue, mild
|
10 participants
|
7 participants
|
13 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.
Muscle aches, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.
Muscle aches, moderate
|
3 participants
|
3 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.
Muscle aches, mild
|
14 participants
|
7 participants
|
12 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.
Headache, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.
Headache, moderate
|
3 participants
|
0 participants
|
1 participants
|
—
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.
Headache, mild
|
8 participants
|
8 participants
|
12 participants
|
—
|
SECONDARY outcome
Timeframe: Days 0-7 after vaccination at Month 6Population: The analysis population includes all participants who received the 6-month boost vaccination.
Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=60 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=60 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=56 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=56 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.
Headache, mild
|
3 participants
|
7 participants
|
9 participants
|
6 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.
Fatigue, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.
Fatigue, moderate
|
6 participants
|
2 participants
|
3 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.
Fatigue, mild
|
9 participants
|
10 participants
|
13 participants
|
13 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.
Muscle aches, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.
Muscle aches, moderate
|
8 participants
|
2 participants
|
6 participants
|
4 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.
Muscle aches, mild
|
13 participants
|
14 participants
|
14 participants
|
15 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.
Headache, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.
Headache, moderate
|
7 participants
|
0 participants
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 0-7 after vaccination at Day 0Population: The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.
Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=66 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=68 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=67 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity
Fever, severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity
Fever, moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity
Fever, mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 0-7 after vaccination at Day 14Population: The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.
Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=65 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=65 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=65 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity
Fever, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity
Fever, moderate
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity
Fever, mild
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 0-7 after vaccination at Day 28Population: The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.
Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=64 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=60 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=61 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity
Fever, severe
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity
Fever, moderate
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity
Fever, mild
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 0-7 after vaccination at Month 6Population: The analysis population includes all participants who received the 6-month boost vaccination and recorded oral temperatures.
Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=60 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=58 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=55 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=56 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity
Fever, severe
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity
Fever, moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity
Fever, mild
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.Population: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.
Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. A participant met the threshold of a 4-fold rise in anti-PA IgG antibody concentration if the post vaccination concentration was an increase by 4-fold or more from the baseline (Day 0) concentration.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=60 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 7
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 14
|
4 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 21
|
25 participants
|
9 participants
|
21 participants
|
11 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 28
|
65 participants
|
9 participants
|
57 participants
|
46 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 35
|
65 participants
|
24 participants
|
59 participants
|
54 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 42
|
65 participants
|
59 participants
|
59 participants
|
57 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 49
|
61 participants
|
59 participants
|
59 participants
|
56 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 56
|
60 participants
|
59 participants
|
59 participants
|
55 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 63
|
57 participants
|
59 participants
|
59 participants
|
53 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 70
|
54 participants
|
58 participants
|
58 participants
|
53 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 84
|
44 participants
|
56 participants
|
57 participants
|
49 participants
|
|
Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)
Day 100
|
38 participants
|
52 participants
|
54 participants
|
48 participants
|
SECONDARY outcome
Timeframe: Day 7 through Day 100Population: The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.
Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. To determine the group peak GMT, the highest titer assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of each subjects' peak titers was calculated along with the 95% confidence intervals.
Outcome measures
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=67 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=59 Participants
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=60 Participants
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100
|
0.74 titer
Interval 0.59 to 0.94
|
2.99 titer
Interval 2.34 to 3.81
|
1.48 titer
Interval 1.22 to 1.81
|
1.00 titer
Interval 0.76 to 1.32
|
Adverse Events
Arm A: 0.50mL BioThrax, Days 0, 14
Serious events: 0 serious events
Other events: 82 other events
Deaths: 0 deaths
Arm B: 0.50mL BioThrax, Days 0, 28
Serious events: 2 serious events
Other events: 82 other events
Deaths: 0 deaths
Arm C: 0.50mL BioThrax, Days 0, 14, 28
Serious events: 1 serious events
Other events: 82 other events
Deaths: 0 deaths
Arm D: 0.25mL BioThrax, Days 0, 14, 28
Serious events: 0 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=82 participants at risk
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=82 participants at risk
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=82 participants at risk
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=82 participants at risk
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/82 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
1.2%
1/82 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
0.00%
0/82 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
0.00%
0/82 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Infections and infestations
Localised infection
|
0.00%
0/82 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
1.2%
1/82 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
0.00%
0/82 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
0.00%
0/82 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/82 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
0.00%
0/82 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
1.2%
1/82 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
0.00%
0/82 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
Other adverse events
| Measure |
Arm A: 0.50mL BioThrax, Days 0, 14
n=82 participants at risk
BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm B: 0.50mL BioThrax, Days 0, 28
n=82 participants at risk
BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm C: 0.50mL BioThrax, Days 0, 14, 28
n=82 participants at risk
BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
Arm D: 0.25mL BioThrax, Days 0, 14, 28
n=82 participants at risk
BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
|
|---|---|---|---|---|
|
Investigations
Respiratory rate increased
|
25.6%
21/82 • Number of events 27 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
30.5%
25/82 • Number of events 34 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
31.7%
26/82 • Number of events 37 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
26.8%
22/82 • Number of events 30 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Fatigue
|
46.3%
38/82 • Number of events 58 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
40.2%
33/82 • Number of events 48 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
48.8%
40/82 • Number of events 74 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
48.8%
40/82 • Number of events 70 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
57.3%
47/82 • Number of events 75 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
42.7%
35/82 • Number of events 58 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
46.3%
38/82 • Number of events 75 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
51.2%
42/82 • Number of events 75 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Nervous system disorders
Headache
|
8.5%
7/82 • Number of events 8 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
6.1%
5/82 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
6.1%
5/82 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
4.9%
4/82 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Vaccination site pain
|
86.6%
71/82 • Number of events 155 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
87.8%
72/82 • Number of events 168 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
87.8%
72/82 • Number of events 185 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
86.6%
71/82 • Number of events 154 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Vaccination site pruritus
|
63.4%
52/82 • Number of events 74 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
53.7%
44/82 • Number of events 64 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
57.3%
47/82 • Number of events 81 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
58.5%
48/82 • Number of events 88 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Vaccination site warmth
|
65.9%
54/82 • Number of events 102 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
59.8%
49/82 • Number of events 88 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
61.0%
50/82 • Number of events 124 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
61.0%
50/82 • Number of events 120 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Tenderness
|
98.8%
81/82 • Number of events 205 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
96.3%
79/82 • Number of events 208 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
97.6%
80/82 • Number of events 251 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
95.1%
78/82 • Number of events 247 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
53.7%
44/82 • Number of events 79 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
47.6%
39/82 • Number of events 59 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
58.5%
48/82 • Number of events 85 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
52.4%
43/82 • Number of events 63 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Vaccination site erythema
|
4.9%
4/82 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
7.3%
6/82 • Number of events 7 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
4.9%
4/82 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
3.7%
3/82 • Number of events 3 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Vaccination site swelling
|
53.7%
44/82 • Number of events 74 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
53.7%
44/82 • Number of events 63 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
48.8%
40/82 • Number of events 73 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
48.8%
40/82 • Number of events 70 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Cardiac disorders
Bradycardia
|
2.4%
2/82 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
4.9%
4/82 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
9.8%
8/82 • Number of events 11 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
8.5%
7/82 • Number of events 11 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/82 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
2.4%
2/82 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
4.9%
4/82 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
6.1%
5/82 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Vascular disorders
Hypertension
|
1.2%
1/82 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
4.9%
4/82 • Number of events 7 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
6.1%
5/82 • Number of events 7 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
2.4%
2/82 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
5/82 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
7.3%
6/82 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
6.1%
5/82 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
7.3%
6/82 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.0%
9/82 • Number of events 9 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
22.0%
18/82 • Number of events 19 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
15.9%
13/82 • Number of events 14 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
12.2%
10/82 • Number of events 11 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Vaccination site bruising
|
7.3%
6/82 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
12.2%
10/82 • Number of events 12 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
4.9%
4/82 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
6.1%
5/82 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Vaccination site nodule
|
76.8%
63/82 • Number of events 109 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
78.0%
64/82 • Number of events 107 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
80.5%
66/82 • Number of events 145 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
73.2%
60/82 • Number of events 129 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Vessel puncture site bruise
|
6.1%
5/82 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
2.4%
2/82 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
3.7%
3/82 • Number of events 3 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
7.3%
6/82 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited AEs through 28 days after last vaccination in the primary series and 21 days after the boost vaccination, and serious adverse events through 201 days after first vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
Additional Information
David Bernstein, MD, MA
Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center
Phone: 513-636-7625
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60