Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults

• Sponsor: Emergent BioSolutions (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01491607
• Collaborator: Department of Health and Human Services (U.S. Fed)
• Enrollment: 200
• Locations: 4
• Arm: 1
• Duration (Months): 6
• Patients Per Site: 50
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief Summary

The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax.

This study will be conducted in the United States (U.S.), in 200 healthy male and female volunteer subjects ages 18 to 65 years.

The duration of study participation for each individual subject will be approximately 128 days (4.25 months), including a screening period of approximately 28 days followed by 100 days on study.

Condition or Disease	Intervention/Treatment	Phase
Anthrax	Biological: BioThrax	Phase 3

Detailed Description

BioThrax® (also called Anthrax Vaccine Adsorbed or AVA) is the only FDA-licensed vaccine for the prevention of anthrax infection. This study will evaluate the immunogenicity of the vaccine using a post-exposure vaccination schedule. Correlations will be drawn to immunogenicity and survival data from animal models to demonstrate that BioThrax® can elicit a protective immune response for PEP.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BioThrax (0.5 mL, on days 0, 14, and 28)	Biological: BioThrax; BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.; Other Names: Anthrax Vaccine Adsorbed (AVA)

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). [Day 63 +/- 2 days]

   Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.

Secondary Outcome Measures

1. Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. [Day 70 +/- 2 days]

   Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.

2. Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). [Days 63 to 100]

   Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.

3. Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards [Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).]

   Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.

4. Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards [Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).]

   Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.

5. Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards [Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).]

   Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.

6. Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards [Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).]

   Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Be between 18 and 65 years of age, inclusive, at the time of enrollment.

• Be in good health as determined by the investigator from medical history and a physical examination.

• If a pre-menopausal female, must be using acceptable methods of birth control.

• Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range.

• Be willing and able to return for all visits and blood collections for the duration of the study.

• Have read, understood and signed an informed consent form.

Exclusion Criteria:

• Prior immunization with anthrax vaccine or known exposure to anthrax organisms.

• Intend to enlist in the military during the study.

• Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex.

• Plan to receive experimental products at any time during the study.

• Have received a live vaccine in the 30 days before study entry.

• Plan to receive a live vaccine at any time during the study.

• Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in a urine drug screen for amphetamines, barbiturates, cocaine or opiates;

• Have received immunosuppressive therapy (including systemic steroids) within 3 months prior to study entry.

• Have a condition known to produce or be associated with immunosuppression.

• Have received cytotoxic therapy in the previous 5 years.

• A medical condition that, in the opinion of the Principal Investigator (PI), could adversely impact the subject's participation, safety, or conduct of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miami Research Associates	Miami	Florida	United States	33143
2	Rochester Clinical Research	Rochester	New York	United States	14609
3	Coastal Carolina Research Center	Mt. Pleasant	South Carolina	United States	29464
4	Jean Brown Research	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

• Emergent BioSolutions
• Department of Health and Human Services

Investigators

• Principal Investigator: Robert Hopkins, MD, MPH, TM, Emergent BioSolutions Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emergent BioSolutions
• ClinicalTrials.gov Identifier: NCT01491607
• Other Study ID Numbers: EBS.AVA.006; HHSO100200700037C
• First Posted: Dec 14, 2011
• Last Update Posted: Nov 28, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Emergent BioSolutions: post-exposure prophylaxis; toxin neutralization assay
• Additional relevant MeSH terms: Anthrax; Vaccines

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from 9 November 2011 to 9 May 2012 at four medical centers in the U.S.
Pre-assignment Detail	All enrolled participants met the inclusion and exclusion criteria.

Arm/Group Title	BioThrax
Arm/Group Description	Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
Period Title: Overall Study
STARTED	200
COMPLETED	190
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	BioThrax - Site 01	BioThrax - Site 02	BioThrax - Site 03	BioThrax - Site 04	Total
Arm/Group Description	Subjects from Site 01 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.	Subjects from Site 02 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.	Subjects from Site 03 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.	Subjects from Site 04 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.	Total of all reporting groups
Overall Participants	45	34	56	49	184
Age (Count of Participants)
<=18 years	1 2.2%	1 2.9%	0 0%	1 2%	3 1.6%
Between 18 and 65 years	44 97.8%	33 97.1%	56 100%	48 98%	181 98.4%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.0 (11.41)	36.7 (10.97)	32.7 (9.89)	34.2 (11.09)	33.7 (10.84)
Sex: Female, Male (Count of Participants)
Female	22 48.9%	19 55.9%	29 51.8%	22 44.9%	92 50%
Male	23 51.1%	15 44.1%	27 48.2%	27 55.1%	92 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 4.4%	15 44.1%	1 1.8%	2 4.1%	20 10.9%
Not Hispanic or Latino	43 95.6%	19 55.9%	55 98.2%	47 95.9%	164 89.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
White	42 93.3%	20 58.8%	49 87.5%	45 91.8%	156 84.8%
Black or African American	0 0%	14 41.2%	3 5.4%	3 6.1%	20 10.9%
Asian	2 4.4%	0 0%	2 3.6%	1 2%	5 2.7%
American Indian or Alaska Native	1 2.2%	0 0%	1 1.8%	0 0%	2 1.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 1.8%	0 0%	1 0.5%
Region of Enrollment (participants) [Number]
United States	45 100%	34 100%	56 100%	49 100%	184 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).
Description	Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.
Time Frame	Day 63 +/- 2 days

Outcome Measure Data

Analysis Population Description

Subjects who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.

Arm/Group Title	BioThrax	BioThrax - Male	BioThrax - Female	BioThrax - ≤ 30 Years of Age	BioThrax- > 30 Years of Age	BioThrax - Caucasian	BioThrax - Non-Caucasian	BioThrax - Site 01	BioThrax - Site 02	BioThrax - Site 03	BioThrax - Site 04
Arm/Group Description	Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	Participants enrolled at Site 02 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	Participants enrolled at Site 03 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	Participants enrolled at Site 04 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
Measure Participants	184	92	92	90	94	156	28	45	34	56	49
Mean (95% Confidence Interval) [percentage of participants]	71.2 158.2%	68.5 201.5%	73.9 132%	76.7 156.5%	66.0 35.9%	73.7 NaN	57.1 NaN	91.1 NaN	67.6 NaN	69.6 NaN	57.1 NaN

2. Secondary Outcome

Title	Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.
Description	Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.
Time Frame	Day 70 +/- 2 days

Outcome Measure Data

Analysis Population Description

Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days.

Arm/Group Title	BioThrax - Day 70	BioThrax - Male	BioThrax - Female	BioThrax - ≤ 30 Years of Age	BioThrax - > 30 Years of Age	BioThrax - Caucasian	BioThrax - Non-Caucasian	BioThrax - Site 01	BioThrax - Site 02	BioThrax - Site 03	BioThrax - Site 04
Arm/Group Description	Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.	Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.	Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.	Participants ≤ 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.	Participants > 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.	Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.	Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.	Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.	Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.	Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.	Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
Measure Participants	183	90	93	88	95	156	27	43	33	57	50
Least Squares Mean (95% Confidence Interval) [percentage of participants]	57.9 128.7%	54.4 160%	61.3 109.5%	67.0 136.7%	49.5 26.9%	61.5 NaN	37.0 NaN	79.1 NaN	42.4 NaN	57.9 NaN	50.0 NaN

3. Secondary Outcome

Title	Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).
Description	Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.
Time Frame	Days 63 to 100

Outcome Measure Data

Analysis Population Description

Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive.

Arm/Group Title	BioThrax - Days 63-100 Immunogenicity	BioThrax - Male	BioThrax - Female	BioThrax - ≤ 30 Years of Age	BioThrax - > 30 Years of Age	BioThrax - Caucasian	BioThrax - Non-Caucasian	BioThrax - Site 01	BioThrax - Site 02	BioThrax - Site 03	BioThrax - Site 04
Arm/Group Description	Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.	Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.	Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.	Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.	Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.	Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.	Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.	Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.	Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.	Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.	Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
Measure Participants	165	82	83	77	88	141	24	36	30	52	47
Mean (95% Confidence Interval) [percentage of participants]	52.7 117.1%	50.0 147.1%	55.4 98.9%	58.4 119.2%	47.7 25.9%	56.0 NaN	33.3 NaN	75.0 NaN	36.7 NaN	51.9 NaN	46.8 NaN

4. Secondary Outcome

Title	Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Description	Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.
Time Frame	Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).

Outcome Measure Data

Analysis Population Description

The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).

Arm/Group Title	BioThrax 1st Vaccination - No Reaction	BioThrax 1st Vaccination - Mild Reaction	BioThrax 1st Vaccination - Moderate Reaction	BioThrax 1st Vaccination - Severe Reaction	BioThrax 1st Vaccination - Total of Reactions	BioThrax 2nd Vaccination - No Reaction	BioThrax 2nd Vaccination - Mild Reaction	BioThrax 2nd Vaccination - Moderate Reaction	BioThrax 2nd Vaccination - Severe Reaction	BioThrax 2nd Vaccination - Total of Reactions	BioThrax 3rd Vaccination - No Reaction	BioThrax 3rd Vaccination - Mild Reaction	BioThrax 3rd Vaccination - Moderate Reaction	BioThrax 3rd Vaccination - Severe Reaction	BioThrax 3rd Vaccination - Total of Reactions
Arm/Group Description	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
Measure Participants	196	196	196	196	196	196	196	196	196	196	193	193	193	193	193
Warmth	93 206.7%	94 276.5%	9 16.1%	0 0%	103 56%	85 NaN	96 NaN	14 NaN	1 NaN	111 NaN	101 NaN	88 NaN	4 NaN	0 NaN	92 NaN
Tenderness	11 24.4%	134 394.1%	49 87.5%	2 4.1%	185 100.5%	11 NaN	126 NaN	57 NaN	2 NaN	185 NaN	36 NaN	139 NaN	18 NaN	0 NaN	157 NaN
Itching	167 371.1%	27 79.4%	1 1.8%	1 2%	29 15.8%	118 NaN	65 NaN	12 NaN	1 NaN	78 NaN	121 NaN	65 NaN	7 NaN	0 NaN	72 NaN
Pain	26 57.8%	123 361.8%	45 80.4%	2 4.1%	170 92.4%	34 NaN	110 NaN	50 NaN	2 NaN	162 NaN	80 NaN	100 NaN	13 NaN	0 NaN	113 NaN
Arm Motion Limitation	102 226.7%	68 200%	22 39.3%	4 8.2%	94 51.1%	102 NaN	66 NaN	27 NaN	1 NaN	94 NaN	137 NaN	51 NaN	5 NaN	0 NaN	56 NaN
Redness	115 255.6%	68 200%	12 21.4%	1 2%	81 44%	84 NaN	80 NaN	30 NaN	2 NaN	112 NaN	109 NaN	70 NaN	14 NaN	0 NaN	84 NaN
Swelling	111 246.7%	78 229.4%	7 12.5%	0 0%	85 46.2%	90 NaN	85 NaN	21 NaN	0 NaN	106 NaN	111 NaN	73 NaN	9 NaN	0 NaN	82 NaN
Lump	82 182.2%	102 300%	11 19.6%	1 2%	114 62%	62 NaN	109 NaN	23 NaN	2 NaN	134 NaN	76 NaN	107 NaN	10 NaN	0 NaN	117 NaN
Bruise	173 384.4%	23 67.6%	0 0%	0 0%	23 12.5%	162 NaN	31 NaN	2 NaN	1 NaN	34 NaN	171 NaN	21 NaN	1 NaN	0 NaN	22 NaN

5. Secondary Outcome

Title	Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Description	Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.
Time Frame	Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).

Outcome Measure Data

Analysis Population Description

The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).

Arm/Group Title	BioThrax 1st Vaccination - No Reaction	BioThrax 1st Vaccination - Mild Reaction	BioThrax 1st Vaccination - Moderate Reaction	BioThrax 1st Vaccination - Severe Reaction	BioThrax 1st Vaccination - Total of Reactions	BioThrax 2nd Vaccination - No Reaction	BioThrax 2nd Vaccination - Mild Reaction	BioThrax 2nd Vaccination - Moderate Reaction	BioThrax 2nd Vaccination - Severe Reaction	BioThrax 2nd Vaccination - Total of Reactions	BioThrax 3rd Vaccination - No Reaction	BioThrax 3rd Vaccination - Mild Reaction	BioThrax 3rd Vaccination - Moderate Reaction	BioThrax 3rd Vaccination - Severe Reaction	BioThrax 3rd Vaccination - Total of Reactions
Arm/Group Description	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
Measure Participants	196	196	196	196	196	196	196	196	196	196	193	193	193	193	193
Warmth	47.4 105.3%	48.0 141.2%	4.6 8.2%	0 0%	52.6 28.6%	43.4 NaN	49.0 NaN	7.1 NaN	0.5 NaN	56.6 NaN	52.3 NaN	45.6 NaN	2.1 NaN	0 NaN	47.7 NaN
Tenderness	5.6 12.4%	68.4 201.2%	25.0 44.6%	1.0 2%	94.4 51.3%	5.6 NaN	64.3 NaN	29.1 NaN	1.0 NaN	94.4 NaN	18.7 NaN	72.0 NaN	9.3 NaN	0 NaN	81.3 NaN
Itching	85.2 189.3%	13.8 40.6%	0.5 0.9%	0.5 1%	14.8 8%	60.2 NaN	33.2 NaN	6.1 NaN	0.5 NaN	39.8 NaN	62.7 NaN	33.7 NaN	3.6 NaN	0 NaN	37.3 NaN
Pain	13.3 29.6%	62.8 184.7%	23.0 41.1%	1.0 2%	86.7 47.1%	17.3 NaN	56.1 NaN	25.5 NaN	1.0 NaN	82.7 NaN	41.5 NaN	51.8 NaN	6.7 NaN	0 NaN	58.5 NaN
Arm Motion Limitation	52.0 115.6%	34.7 102.1%	11.2 20%	2.0 4.1%	48.0 26.1%	52.0 NaN	33.7 NaN	13.8 NaN	0.5 NaN	48.0 NaN	71.0 NaN	26.4 NaN	2.6 NaN	0 NaN	29.0 NaN
Redness	58.7 130.4%	34.7 102.1%	6.1 10.9%	0.5 1%	41.3 22.4%	42.9 NaN	40.8 NaN	15.3 NaN	1.0 NaN	57.1 NaN	65.5 NaN	36.3 NaN	7.3 NaN	0 NaN	43.5 NaN
Swelling	56.6 125.8%	39.8 117.1%	3.6 6.4%	0 0%	43.4 23.6%	45.9 NaN	43.4 NaN	10.7 NaN	0 NaN	54.1 NaN	57.5 NaN	37.8 NaN	4.7 NaN	0 NaN	42.5 NaN
Lump	41.8 92.9%	52.0 152.9%	5.6 10%	0.5 1%	58.2 31.6%	31.6 NaN	55.6 NaN	11.7 NaN	1.0 NaN	68.4 NaN	39.4 NaN	55.4 NaN	5.2 NaN	0 NaN	60.6 NaN
Bruise	88.3 196.2%	11.7 34.4%	0 0%	0 0%	11.7 6.4%	82.7 NaN	15.8 NaN	1.0 NaN	0.5 NaN	17.3 NaN	88.6 NaN	10.9 NaN	0.5 NaN	0 NaN	11.4 NaN

6. Secondary Outcome

Title	Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Description	Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.
Time Frame	Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).

Outcome Measure Data

Analysis Population Description

The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).

Arm/Group Title	BioThrax 1st Vaccination - No Reaction	BioThrax 1st Vaccination - Mild Reaction	BioThrax 1st Vaccination - Moderate Reaction	BioThrax 1st Vaccination - Severe Reaction	BioThrax 1st Vaccination - Total of Reactions	BioThrax 2nd Vaccination - No Reaction	BioThrax 2nd Vaccination - Mild Reaction	BioThrax 2nd Vaccination - Moderate Reaction	BioThrax 2nd Vaccination - Severe Reaction	BioThrax 2nd Vaccination - Total of Reactions	BioThrax 3rd Vaccination - No Reaction	BioThrax 3rd Vaccination - Mild Reaction	BioThrax 3rd Vaccination - Moderate Reaction	BioThrax 3rd Vaccination - Severe Reaction	BioThrax 3rd Vaccination - Total of Reactions
Arm/Group Description	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
Measure Participants	196	196	196	196	196	196	196	196	196	196	193	193	193	193	193
Fatigue/Tiredness	138 306.7%	48 141.2%	10 17.9%	0 0%	58 31.5%	135 NaN	48 NaN	12 NaN	1 NaN	61 NaN	151 NaN	38 NaN	4 NaN	0 NaN	42 NaN
Muscle Ache	86 191.1%	90 264.7%	19 33.9%	1 2%	110 59.8%	101 NaN	67 NaN	27 NaN	1 NaN	95 NaN	125 NaN	63 NaN	5 NaN	0 NaN	68 NaN
Headache	147 326.7%	38 111.8%	9 16.1%	2 4.1%	49 26.6%	140 NaN	40 NaN	15 NaN	1 NaN	56 NaN	143 NaN	38 NaN	12 NaN	0 NaN	50 NaN
Fever	195 433.3%	0 0%	1 1.8%	0 0%	1 0.5%	196 NaN	0 NaN	0 NaN	0 NaN	0 NaN	192 NaN	1 NaN	0 NaN	0 NaN	1 NaN

7. Secondary Outcome

Title	Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Description	Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.
Time Frame	Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).

Outcome Measure Data

Analysis Population Description

The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).

Arm/Group Title	BioThrax 1st Vaccination - No Reaction	BioThrax 1st Vaccination - Mild Reaction	BioThrax 1st Vaccination - Moderate Reaction	BioThrax 1st Vaccination - Severe Reaction	BioThrax 1st Vaccination - Total of Reactions	BioThrax 2nd Vaccination - No Reaction	BioThrax 2nd Vaccination - Mild Reaction	BioThrax 2nd Vaccination - Moderate Reaction	BioThrax 2nd Vaccination - Severe Reaction	BioThrax 2nd Vaccination - Total of Reactions	BioThrax 3rd Vaccination - No Reaction	BioThrax 3rd Vaccination - Mild Reaction	BioThrax 3rd Vaccination - Moderate Reaction	BioThrax 3rd Vaccination - Severe Reaction	BioThrax 3rd Vaccination - Total of Reactions
Arm/Group Description	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
Measure Participants	196	196	196	196	196	196	196	196	196	196	193	193	193	193	193
Fatigue/Tiredness	70.4 156.4%	24.5 72.1%	5.1 9.1%	0 0%	29.6 16.1%	68.9 NaN	24.5 NaN	6.1 NaN	0.5 NaN	31.1 NaN	78.2 NaN	19.7 NaN	2.1 NaN	0 NaN	21.8 NaN
Muscle Ache	43.9 97.6%	45.9 135%	9.7 17.3%	0.5 1%	56.1 30.5%	51.5 NaN	34.2 NaN	13.8 NaN	0.5 NaN	48.5 NaN	64.8 NaN	32.6 NaN	2.6 NaN	0 NaN	35.2 NaN
Headache	75.0 166.7%	19.4 57.1%	4.6 8.2%	1.0 2%	25.0 13.6%	71.4 NaN	20.4 NaN	7.7 NaN	0.5 NaN	28.6 NaN	74.1 NaN	19.7 NaN	6.2 NaN	0 NaN	25.9 NaN
Fever	99.25 220.6%	0 0%	0.5 0.9%	0 0%	0.5 0.3%	100 NaN	0 NaN	0 NaN	0 NaN	0 NaN	99.5 NaN	0.5 NaN	0 NaN	0 NaN	0.5 NaN

Adverse Events

Time Frame	Adverse event data were collected from the time of screening up to 100 days post dose.
Arm/Group Title	ITT Population
Arm/Group Description	Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
All Cause Mortality
	ITT Population
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ITT Population
	Affected / at Risk (%)	# Events
Total	2/200 (1%)
Metabolism and nutrition disorders
Obesity	1/200 (0.5%)	1
Nervous system disorders
Aura	1/200 (0.5%)	1
Other (Not Including Serious) Adverse Events
	ITT Population
	Affected / at Risk (%)	# Events
Total	109/200 (54.5%)
General disorders
Fatigue	13/200 (6.5%)	17
Infections and infestations
Upper respiratory tract infection	37/200 (18.5%)	44
Nasopharyngitis	10/200 (5%)	11
Musculoskeletal and connective tissue disorders
Myalgia	12/200 (6%)	14
Nervous system disorders
Headache	25/200 (12.5%)	31
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	12/200 (6%)	12

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor is responsible for public disclosure of study data. Any proposed publication is subject to review agreed between Biomedical Advanced Research and Development Authority (BARDA)and Emergent; between Emergent and the contract research organizations (CROs)/vendors; and between the CROs and the site Principal Investigator. Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, but data and publication thereof will not be unduly withheld.