Bacillus Anthracis (Anthrax)
Conditions
Keywords
Bacillus anthracis, anthrax, vaccine, BioThrax®, dose-sparing
Brief summary
A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of BioThrax® in varying dose regimens with the primary objective of obtaining information on possible dose-sparing strategies in the event of a major biothreat.
Detailed description
This is a Phase IV, randomized, open-label immunogenicity and safety study to evaluate four dosing regimens of BioThrax® for Post-Exposure Prophylaxis (PEP) for anthrax. BioThrax® will be administered as a subcutaneous (SC) injection for the primary series and will be administered as an intramuscular (IM) injection for the boost. The four dosing regimens are: 0.50mL BioThrax® on Days 0, 14, and 6 month boost; 0.50mL BioThrax® on Days 0, 28 and 6 month boost; 0.50mL BioThrax® on Days 0, 14, 28 and 6 month boost and 0.25mL BioThrax® on Days 0, 14, and 28, 6 month boost with 0.50ml IM Approximately 300 subjects will be randomized 1:1:1:1 to one of the four study arms. Enrollment will be stratified by gender, with approximately equal numbers of males and females (18 through 65 years) enrolled into each dosing regimen. The Primary objective is to evaluate the immunogenicity of the four dosing regimens of BioThrax® using the Toxin Neutralization Assay (TNA). The secondary objective is to evaluate the safety of the four dosing regimens of BioThrax®.
Interventions
BIOLOGICALBioThrax®
BioThrax® is a sterile, milky white suspension made from cell free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, will be administered as a 0.50mL IM injection 6 month boost for all groups
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject able to provide informed consent; * Female or male, 18 through 65 years of age, inclusive; * If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men (vaginal penetration by a penis, coitus) or use acceptable contraception, initiated at least 30 days prior to the first study vaccination through 56 days after the 6 month boost vaccination in order to avoid pregnancy: 1. A woman is considered of childbearing potential unless post-menopausal (\>/= 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy) 2. Acceptable contraception methods are restricted to effective devices (IUDs, NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, condoms with spermicidal agents, monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to study entry, or successful Essure placement with documented confirmation test at least 3 months after the procedure, and any other Food and Drug Administration (FDA)-approved contraceptive method * Be willing and able to return for all visits and blood collections for the duration of the study; * Be able to understand and comply with planned study procedures; * Agree to complete the memory aid and to report concomitant medications and Adverse Events during the study period. Further clarification of inclusion/
Exclusion criteria
Provided a subject meets all study inclusion criteria and none of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Days 0, 7, 14, 21, 28 35, 42, 49, 56, 63, 70, 84 and 100 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Days 0-7 after vaccination at Day 0 | 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. |
| Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Days 0-7 after vaccination at Day 14 | 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. |
| Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Days 0-7 after vaccination at Day 28 | 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. |
| Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Days 0-7 after vaccination at Month 6 | 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. |
| Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Days 0-7 after each vaccination | 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. |
| TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | 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. |
| Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100 | Day 7 through Day 100 | 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. |
| Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Days 0-7 after vaccination at Day 0 | 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. |
| Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | 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. |
| Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Days 0-7 after vaccination at Day 28 | 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. |
| Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Days 0-7 after vaccination at Month 6 | 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. |
| Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Day 0-7 after vaccination at Day 0 | 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. |
| Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity | Day 0-7 after vaccination at Day 14 | 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. |
| Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity | Day 0-7 after vaccination at Day 28 | 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. |
| Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Day 0-7 after vaccination at Month 6 | 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. |
| 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) | Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | 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. |
| TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100 | Day 7 through Day 100 | 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. |
| Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Days 0-7 after vaccination at Day 14 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 82 |
| 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 | 82 |
| 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 | 82 |
| 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 | 82 |
| Total | 328 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 | 3 | 1 |
| Overall Study | no longer eligible | 2 | 1 | 0 | 4 |
| Overall Study | Physician Decision | 0 | 1 | 7 | 5 |
| Overall Study | Pregnancy | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 1 | 5 |
Baseline characteristics
| Characteristic | Total | Arm A: 0.50mL BioThrax, Days 0, 14 | Arm B: 0.50mL BioThrax, Days 0, 28 | Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Arm D: 0.25mL BioThrax, Days 0, 14, 28 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 328 Participants | 82 Participants | 82 Participants | 82 Participants | 82 Participants |
| Age, Continuous | 35.7 years STANDARD_DEVIATION 11.2 | 35.0 years STANDARD_DEVIATION 10.8 | 36.7 years STANDARD_DEVIATION 11.7 | 34.6 years STANDARD_DEVIATION 11.5 | 36.5 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 6 Participants | 4 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 309 Participants | 76 Participants | 78 Participants | 79 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 55 Participants | 7 Participants | 14 Participants | 19 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 6 Participants | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 245 Participants | 67 Participants | 61 Participants | 56 Participants | 61 Participants |
| Region of Enrollment United States | 328 participants | 82 participants | 82 participants | 82 participants | 82 participants |
| Sex: Female, Male Female | 166 Participants | 43 Participants | 42 Participants | 40 Participants | 41 Participants |
| Sex: Female, Male Male | 162 Participants | 39 Participants | 40 Participants | 42 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 82 / 82 | 82 / 82 | 82 / 82 | 82 / 82 |
| serious Total, serious adverse events | 0 / 82 | 2 / 82 | 1 / 82 | 0 / 82 |
Outcome results
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 1 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 59 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 13 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 59 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 59 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 59 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 32 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 12 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 54 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 58 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 19 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 56 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 59 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 59 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 59 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 59 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 59 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 58 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 56 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 58 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 53 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 54 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 46 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 12 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 44 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 51 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 55 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 56 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 54 participants |
Secondary
Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 42 | 76.32 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 49 | 61.77 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 63 | 41.87 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 56 | 52.95 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 14 | 6.16 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 0 | 4.64 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 84 | 25.75 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 21 | 13.67 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 28 | 88.43 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 7 | 5.01 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 70 | 36.32 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 35 | 89.44 µg/mL |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 100 | 19.38 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 7 | 4.71 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 0 | 4.64 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 63 | 128.92 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 21 | 7.62 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 49 | 201.87 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 84 | 70.14 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 100 | 51.22 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 70 | 105.14 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 56 | 158.13 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 42 | 253.53 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 14 | 5.48 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 28 | 7.62 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 35 | 17.16 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 63 | 99.20 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 0 | 4.64 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 7 | 4.91 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 14 | 5.28 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 21 | 12.11 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 28 | 84.05 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 35 | 154.49 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 42 | 170.40 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 49 | 141.93 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 56 | 119.28 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 70 | 87.13 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 84 | 65.42 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 100 | 48.77 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 35 | 86.74 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 63 | 66.54 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 28 | 52.13 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 21 | 7.63 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 0 | 4.64 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 70 | 56.48 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 14 | 5.01 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 7 | 4.70 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 100 | 32.53 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 84 | 43.30 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 56 | 77.77 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 49 | 93.07 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG) | Day 42 | 108.26 µg/mL |
Secondary
Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity
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.
Time frame: Day 0-7 after vaccination at Month 6
Population: The analysis population includes all participants who received the 6-month boost vaccination and recorded oral temperatures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, mild | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, moderate | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, moderate | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, mild | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, mild | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, severe | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, moderate | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, moderate | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, severe | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity | Fever, mild | 1 participants |
Secondary
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity
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.
Time frame: Day 0-7 after vaccination at Day 0
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, mild | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, moderate | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, moderate | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, mild | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, moderate | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, mild | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, mild | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, moderate | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity | Fever, severe | 0 participants |
Secondary
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity
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.
Time frame: Day 0-7 after vaccination at Day 14
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity | Fever, moderate | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity | Fever, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity | Fever, mild | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity | Fever, moderate | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity | Fever, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity | Fever, mild | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity | Fever, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity | Fever, mild | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity | Fever, moderate | 0 participants |
Secondary
Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity
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.
Time frame: Day 0-7 after vaccination at Day 28
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity | Fever, mild | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity | Fever, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity | Fever, moderate | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity | Fever, moderate | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity | Fever, mild | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity | Fever, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity | Fever, mild | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity | Fever, moderate | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity | Fever, severe | 0 participants |
Secondary
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity
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.
Time frame: Days 0-7 after vaccination at Month 6
Population: The analysis population includes all participants who received the 6-month booster vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Erythema, mild | 1 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 1 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 42 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 8 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 29 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Edema, moderate | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Erythema, moderate | 3 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 6 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 9 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Edema, mild | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 1 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 9 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 9 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 10 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 6 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Erythema, mild | 5 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 4 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 15 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 15 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 28 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Edema, mild | 2 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 14 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Edema, moderate | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Erythema, severe | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 27 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Erythema, moderate | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 3 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 14 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 1 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Edema, moderate | 2 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 1 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 18 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 13 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Erythema, mild | 1 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 6 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 20 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity | Edema, mild | 2 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 9 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 1 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 13 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 1 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 30 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
Secondary
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity
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.
Time frame: Days 0-7 after vaccination at Day 0
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 25 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Erythema, mild | 23 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 15 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 44 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 13 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Edema, moderate | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Edema, mild | 17 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 4 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 12 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Erythema, severe | 1 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 41 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 12 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Erythema, moderate | 4 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 42 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 45 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 9 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Erythema, mild | 21 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 28 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Edema, mild | 17 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 18 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 15 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Edema, moderate | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 12 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 7 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 6 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 10 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Erythema, moderate | 3 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Erythema, mild | 17 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Edema, moderate | 1 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity | Edema, mild | 11 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 8 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 35 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 10 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 21 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 10 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 42 participants |
Secondary
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity
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.
Time frame: Days 0-7 after vaccination at Day 14
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 12 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 37 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 21 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 31 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 16 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 43 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 20 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Erythema, severe | 3 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Erythema, moderate | 11 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Erythema, mild | 12 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Edema, moderate | 7 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Edema, mild | 18 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 2 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 4 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 7 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Edema, mild | 11 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Erythema, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 22 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Edema, moderate | 5 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Erythema, moderate | 9 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 3 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Erythema, mild | 15 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 14 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 43 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 35 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 27 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity | Edema, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 4 participants |
Secondary
Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity
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.
Time frame: Days 0-7 after vaccination at Day 28
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Erythema, severe | 1 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Erythema, moderate | 6 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Erythema, mild | 15 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Edema, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Edema, moderate | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Edema, mild | 13 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 3 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 24 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 1 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 3 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 18 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 30 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 1 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 3 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 43 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 7 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 2 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Erythema, moderate | 7 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 27 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 5 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Edema, mild | 15 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 4 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Erythema, severe | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 43 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 4 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Edema, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 24 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity | Erythema, mild | 17 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 17 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 1 participants |
Secondary
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.
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.
Time frame: Days 0-7 after vaccination at Month 6
Population: The analysis population includes all participants who received the 6-month boost vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, moderate | 6 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, mild | 3 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, mild | 9 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, moderate | 7 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, moderate | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, mild | 7 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, moderate | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, mild | 10 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Muscle aches, moderate | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Muscle aches, mild | 14 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Muscle aches, moderate | 6 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, moderate | 3 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, mild | 13 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, moderate | 4 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, mild | 9 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Muscle aches, mild | 14 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, moderate | 1 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Muscle aches, mild | 15 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Muscle aches, moderate | 4 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, severe | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Fatigue, mild | 13 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, mild | 6 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity. | Headache, moderate | 1 participants |
Secondary
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.
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.
Time frame: Days 0-7 after vaccination at Day 0
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, mild | 9 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, mild | 9 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, moderate | 2 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, moderate | 6 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, moderate | 6 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, mild | 15 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, mild | 13 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, moderate | 6 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, mild | 12 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, moderate | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, mild | 16 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, moderate | 3 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, mild | 12 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, moderate | 7 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, mild | 12 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, moderate | 8 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, mild | 15 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, moderate | 4 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, severe | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, moderate | 3 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, severe | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, moderate | 4 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, moderate | 3 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Headache, mild | 18 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, mild | 14 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Fatigue, mild | 15 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity. | Muscle aches, severe | 0 participants |
Secondary
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.
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.
Time frame: Days 0-7 after vaccination at Day 14
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Headache, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Muscle aches, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Fatigue, moderate | 7 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Muscle aches, mild | 18 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Muscle aches, moderate | 7 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Headache, moderate | 4 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Fatigue, mild | 17 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Headache, mild | 14 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Muscle aches, moderate | 6 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Fatigue, moderate | 3 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Fatigue, mild | 15 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Muscle aches, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Muscle aches, mild | 13 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Headache, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Headache, moderate | 4 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Headache, mild | 17 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Fatigue, mild | 10 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Headache, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Fatigue, moderate | 5 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Headache, mild | 11 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Muscle aches, moderate | 3 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Muscle aches, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Headache, moderate | 4 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity. | Muscle aches, mild | 14 participants |
Secondary
Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.
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.
Time frame: Days 0-7 after vaccination at Day 28
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Muscle aches, mild | 14 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Fatigue, moderate | 2 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Headache, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Headache, mild | 8 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Fatigue, mild | 10 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Muscle aches, severe | 0 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Muscle aches, moderate | 3 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Headache, moderate | 3 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Fatigue, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Fatigue, mild | 7 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Muscle aches, mild | 7 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Headache, severe | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Fatigue, moderate | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Headache, moderate | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Muscle aches, moderate | 3 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Headache, mild | 8 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Muscle aches, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Headache, mild | 12 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Fatigue, severe | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Fatigue, moderate | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Fatigue, mild | 13 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Muscle aches, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Muscle aches, moderate | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Muscle aches, mild | 12 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Headache, severe | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity. | Headache, moderate | 1 participants |
Secondary
Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm)
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.
Time frame: Days 0-7 after each vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Edema | 1 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Edema and/or Erythema | 1 participants |
| Arm A: 0.50mL BioThrax, Days 0, 14 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Erythema | 1 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Edema | 1 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Edema and/or Erythema | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Erythema | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Erythema | 2 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Edema | 1 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Edema and/or Erythema | 2 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Edema | 0 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Edema and/or Erythema | 1 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm) | Erythema | 1 participants |
Secondary
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)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 59 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 9 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 0 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 2 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 9 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 24 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 59 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 59 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 59 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 58 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 56 participants |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 | 52 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 57 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 59 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 59 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 59 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 21 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 58 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 57 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 54 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 59 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 0 participants |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 | 59 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 54 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 57 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 53 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 49 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 46 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 56 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 53 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 1 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 48 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 55 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 11 participants |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 | 0 participants |
Secondary
Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100
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.
Time frame: Day 7 through Day 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100 | 102.32 µg/mL |
| Arm B: 0.50mL BioThrax, Days 0, 28 | Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100 | 265.08 µg/mL |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100 | 182.42 µg/mL |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100 | 114.42 µg/mL |
Secondary
TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm A: 0.50mL BioThrax, Days 0, 14 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 21 | 0.06 titer |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 100 | 0.44 titer |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 70 | 1.00 titer |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 49 | 2.19 titer |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 63 | 1.27 titer |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 56 | 1.62 titer |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 35 | 0.17 titer |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 28 | 0.06 titer |
| Arm B: 0.50mL BioThrax, Days 0, 28 | 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 |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 84 | 0.64 titer |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 42 | 2.85 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 70 | 0.60 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 21 | 0.08 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 28 | 0.65 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 100 | 0.34 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 35 | 1.22 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 42 | 1.33 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 84 | 0.45 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 49 | 1.02 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 56 | 0.83 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 63 | 0.71 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 63 | 0.51 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 49 | 0.74 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 21 | 0.05 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 42 | 0.91 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 35 | 0.75 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 14 | 0.03 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | 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 |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 28 | 0.38 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 56 | 0.61 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 100 | 0.24 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 84 | 0.30 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100. | Day 70 | 0.44 titer |
Secondary
TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100
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.
Time frame: Day 7 through Day 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arm A: 0.50mL BioThrax, Days 0, 14 | TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100 | 0.74 titer |
| Arm B: 0.50mL BioThrax, Days 0, 28 | TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100 | 2.99 titer |
| Arm C: 0.50mL BioThrax, Days 0, 14, 28 | TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100 | 1.48 titer |
| Arm D: 0.25mL BioThrax, Days 0, 14, 28 | TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100 | 1.00 titer |