Anthrax
Conditions
Keywords
post-exposure prophylaxis, toxin neutralization assay
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.
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.
Interventions
BIOLOGICALBioThrax
BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.
Sponsors
Department of Health and Human Services
Emergent BioSolutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
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 details
All enrolled participants met the inclusion and exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| BioThrax - Site 01 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. | 45 |
| BioThrax - Site 02 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. | 34 |
| BioThrax - Site 03 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. | 56 |
| BioThrax - Site 04 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. | 49 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | BioThrax - Site 01 | Total | BioThrax - Site 04 | BioThrax - Site 03 | BioThrax - Site 02 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 181 Participants | 48 Participants | 56 Participants | 33 Participants |
| Age, Continuous | 32.0 years STANDARD_DEVIATION 11.41 | 33.7 years STANDARD_DEVIATION 10.84 | 34.2 years STANDARD_DEVIATION 11.09 | 32.7 years STANDARD_DEVIATION 9.89 | 36.7 years STANDARD_DEVIATION 10.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 20 Participants | 2 Participants | 1 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 164 Participants | 47 Participants | 55 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 2 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 5 participants | 1 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 20 participants | 3 participants | 3 participants | 14 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 42 participants | 156 participants | 45 participants | 49 participants | 20 participants |
| Region of Enrollment United States | 45 participants | 184 participants | 49 participants | 56 participants | 34 participants |
| Sex: Female, Male Female | 22 Participants | 92 Participants | 22 Participants | 29 Participants | 19 Participants |
| Sex: Female, Male Male | 23 Participants | 92 Participants | 27 Participants | 27 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 109 / 200 |
| serious Total, serious adverse events | 2 / 200 |
Outcome results
Primary
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).
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
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| BioThrax | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 71.2 percentage of participants |
| BioThrax - Male | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 68.5 percentage of participants |
| BioThrax - Female | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 73.9 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 76.7 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 66.0 percentage of participants |
| BioThrax - Caucasian | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 73.7 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 57.1 percentage of participants |
| BioThrax - Site 01 | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 91.1 percentage of participants |
| BioThrax - Site 02 | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 67.6 percentage of participants |
| BioThrax - Site 03 | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 69.6 percentage of participants |
| BioThrax - Site 04 | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). | 57.1 percentage of participants |
Secondary
Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).
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
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| BioThrax | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 52.7 percentage of participants |
| BioThrax - Male | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 50.0 percentage of participants |
| BioThrax - Female | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 55.4 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 58.4 percentage of participants |
| BioThrax- > 30 Years of Age | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 47.7 percentage of participants |
| BioThrax - Caucasian | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 56.0 percentage of participants |
| BioThrax - Non-Caucasian | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 33.3 percentage of participants |
| BioThrax - Site 01 | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 75.0 percentage of participants |
| BioThrax - Site 02 | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 36.7 percentage of participants |
| BioThrax - Site 03 | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 51.9 percentage of participants |
| BioThrax - Site 04 | Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 46.8 percentage of participants |
Secondary
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
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).
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 82 participants |
| BioThrax | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 115 participants |
| BioThrax | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 26 participants |
| BioThrax | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 102 participants |
| BioThrax | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 167 participants |
| BioThrax | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 11 participants |
| BioThrax | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 173 participants |
| BioThrax | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 111 participants |
| BioThrax | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 93 participants |
| BioThrax - Male | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 102 participants |
| BioThrax - Male | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 68 participants |
| BioThrax - Male | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 78 participants |
| BioThrax - Male | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 27 participants |
| BioThrax - Male | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 134 participants |
| BioThrax - Male | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 23 participants |
| BioThrax - Male | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 94 participants |
| BioThrax - Male | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 123 participants |
| BioThrax - Male | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 68 participants |
| BioThrax - Female | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 12 participants |
| BioThrax - Female | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 45 participants |
| BioThrax - Female | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 1 participants |
| BioThrax - Female | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 9 participants |
| BioThrax - Female | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 11 participants |
| BioThrax - Female | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 49 participants |
| BioThrax - Female | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 7 participants |
| BioThrax - Female | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 0 participants |
| BioThrax - Female | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 22 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 0 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 1 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 4 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 2 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 1 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 0 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 0 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 1 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 2 participants |
| BioThrax- > 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 114 participants |
| BioThrax- > 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 170 participants |
| BioThrax- > 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 29 participants |
| BioThrax- > 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 81 participants |
| BioThrax- > 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 85 participants |
| BioThrax- > 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 23 participants |
| BioThrax- > 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 103 participants |
| BioThrax- > 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 94 participants |
| BioThrax- > 30 Years of Age | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 185 participants |
| BioThrax - Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 90 participants |
| BioThrax - Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 84 participants |
| BioThrax - Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 34 participants |
| BioThrax - Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 102 participants |
| BioThrax - Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 118 participants |
| BioThrax - Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 162 participants |
| BioThrax - Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 62 participants |
| BioThrax - Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 11 participants |
| BioThrax - Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 85 participants |
| BioThrax - Non-Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 80 participants |
| BioThrax - Non-Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 65 participants |
| BioThrax - Non-Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 126 participants |
| BioThrax - Non-Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 110 participants |
| BioThrax - Non-Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 31 participants |
| BioThrax - Non-Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 96 participants |
| BioThrax - Non-Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 66 participants |
| BioThrax - Non-Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 85 participants |
| BioThrax - Non-Caucasian | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 109 participants |
| BioThrax - Site 01 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 21 participants |
| BioThrax - Site 01 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 27 participants |
| BioThrax - Site 01 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 57 participants |
| BioThrax - Site 01 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 23 participants |
| BioThrax - Site 01 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 30 participants |
| BioThrax - Site 01 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 2 participants |
| BioThrax - Site 01 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 14 participants |
| BioThrax - Site 01 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 12 participants |
| BioThrax - Site 01 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 50 participants |
| BioThrax - Site 02 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 1 participants |
| BioThrax - Site 02 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 2 participants |
| BioThrax - Site 02 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 1 participants |
| BioThrax - Site 02 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 2 participants |
| BioThrax - Site 02 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 1 participants |
| BioThrax - Site 02 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 2 participants |
| BioThrax - Site 02 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 2 participants |
| BioThrax - Site 02 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 1 participants |
| BioThrax - Site 02 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 0 participants |
| BioThrax - Site 03 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 112 participants |
| BioThrax - Site 03 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 34 participants |
| BioThrax - Site 03 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 134 participants |
| BioThrax - Site 03 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 78 participants |
| BioThrax - Site 03 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 106 participants |
| BioThrax - Site 03 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 162 participants |
| BioThrax - Site 03 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 94 participants |
| BioThrax - Site 03 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 185 participants |
| BioThrax - Site 03 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 111 participants |
| BioThrax - Site 04 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 111 participants |
| BioThrax - Site 04 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 121 participants |
| BioThrax - Site 04 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 80 participants |
| BioThrax - Site 04 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 76 participants |
| BioThrax - Site 04 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 101 participants |
| BioThrax - Site 04 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 36 participants |
| BioThrax - Site 04 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 137 participants |
| BioThrax - Site 04 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 109 participants |
| BioThrax - Site 04 | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 171 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 107 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 51 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 100 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 70 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 88 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 65 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 139 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 21 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 73 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 9 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 10 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 5 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 13 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 7 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 14 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 1 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 18 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 4 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 0 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 82 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 84 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 117 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 56 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 22 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 92 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 113 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 157 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 72 participants |
Secondary
Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
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).
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 86 participants |
| BioThrax | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 147 participants |
| BioThrax | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 138 participants |
| BioThrax | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 195 participants |
| BioThrax - Male | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 38 participants |
| BioThrax - Male | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 90 participants |
| BioThrax - Male | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 participants |
| BioThrax - Male | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 48 participants |
| BioThrax - Female | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 19 participants |
| BioThrax - Female | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 1 participants |
| BioThrax - Female | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 9 participants |
| BioThrax - Female | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 10 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 1 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 2 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 participants |
| BioThrax - ≤ 30 Years of Age | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 0 participants |
| BioThrax- > 30 Years of Age | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 1 participants |
| BioThrax- > 30 Years of Age | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 58 participants |
| BioThrax- > 30 Years of Age | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 49 participants |
| BioThrax- > 30 Years of Age | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 110 participants |
| BioThrax - Caucasian | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 135 participants |
| BioThrax - Caucasian | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 101 participants |
| BioThrax - Caucasian | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 196 participants |
| BioThrax - Caucasian | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 140 participants |
| BioThrax - Non-Caucasian | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 40 participants |
| BioThrax - Non-Caucasian | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 48 participants |
| BioThrax - Non-Caucasian | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 67 participants |
| BioThrax - Non-Caucasian | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 participants |
| BioThrax - Site 01 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 15 participants |
| BioThrax - Site 01 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 participants |
| BioThrax - Site 01 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 27 participants |
| BioThrax - Site 01 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 12 participants |
| BioThrax - Site 02 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 1 participants |
| BioThrax - Site 02 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 1 participants |
| BioThrax - Site 02 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 1 participants |
| BioThrax - Site 02 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 participants |
| BioThrax - Site 03 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 61 participants |
| BioThrax - Site 03 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 95 participants |
| BioThrax - Site 03 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 participants |
| BioThrax - Site 03 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 56 participants |
| BioThrax - Site 04 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 143 participants |
| BioThrax - Site 04 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 125 participants |
| BioThrax - Site 04 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 151 participants |
| BioThrax - Site 04 | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 192 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 38 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 38 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 63 participants |
| BioThrax 3rd Vaccination - Mild Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 1 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 4 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 5 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 12 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 participants |
| BioThrax 3rd Vaccination - Severe Reaction | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 0 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 1 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 50 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 68 participants |
| BioThrax 3rd Vaccination - Total of Reactions | Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 42 participants |
Secondary
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
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).
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 47.4 percentage of participants |
| BioThrax | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 56.6 percentage of participants |
| BioThrax | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 88.3 percentage of participants |
| BioThrax | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 58.7 percentage of participants |
| BioThrax | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 13.3 percentage of participants |
| BioThrax | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 5.6 percentage of participants |
| BioThrax | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 52.0 percentage of participants |
| BioThrax | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 41.8 percentage of participants |
| BioThrax | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 85.2 percentage of participants |
| BioThrax - Male | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 52.0 percentage of participants |
| BioThrax - Male | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 68.4 percentage of participants |
| BioThrax - Male | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 39.8 percentage of participants |
| BioThrax - Male | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 62.8 percentage of participants |
| BioThrax - Male | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 48.0 percentage of participants |
| BioThrax - Male | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 11.7 percentage of participants |
| BioThrax - Male | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 34.7 percentage of participants |
| BioThrax - Male | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 13.8 percentage of participants |
| BioThrax - Male | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 34.7 percentage of participants |
| BioThrax - Female | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 6.1 percentage of participants |
| BioThrax - Female | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 4.6 percentage of participants |
| BioThrax - Female | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 0 percentage of participants |
| BioThrax - Female | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 5.6 percentage of participants |
| BioThrax - Female | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 23.0 percentage of participants |
| BioThrax - Female | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 0.5 percentage of participants |
| BioThrax - Female | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 11.2 percentage of participants |
| BioThrax - Female | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 3.6 percentage of participants |
| BioThrax - Female | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 25.0 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 1.0 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 0 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 0.5 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 2.0 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 0 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 0.5 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 1.0 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 0.5 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 0 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 58.2 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 41.3 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 94.4 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 14.8 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 48.0 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 52.6 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 86.7 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 11.7 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 43.4 percentage of participants |
| BioThrax - Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 45.9 percentage of participants |
| BioThrax - Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 17.3 percentage of participants |
| BioThrax - Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 5.6 percentage of participants |
| BioThrax - Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 82.7 percentage of participants |
| BioThrax - Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 52.0 percentage of participants |
| BioThrax - Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 42.9 percentage of participants |
| BioThrax - Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 60.2 percentage of participants |
| BioThrax - Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 43.4 percentage of participants |
| BioThrax - Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 31.6 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 33.2 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 15.8 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 56.1 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 33.7 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 40.8 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 43.4 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 49.0 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 55.6 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 64.3 percentage of participants |
| BioThrax - Site 01 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 10.7 percentage of participants |
| BioThrax - Site 01 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 1.0 percentage of participants |
| BioThrax - Site 01 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 7.1 percentage of participants |
| BioThrax - Site 01 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 6.1 percentage of participants |
| BioThrax - Site 01 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 29.1 percentage of participants |
| BioThrax - Site 01 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 13.8 percentage of participants |
| BioThrax - Site 01 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 15.3 percentage of participants |
| BioThrax - Site 01 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 25.5 percentage of participants |
| BioThrax - Site 01 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 11.7 percentage of participants |
| BioThrax - Site 02 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 1.0 percentage of participants |
| BioThrax - Site 02 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 1.0 percentage of participants |
| BioThrax - Site 02 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 0.5 percentage of participants |
| BioThrax - Site 02 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 0.5 percentage of participants |
| BioThrax - Site 02 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 0 percentage of participants |
| BioThrax - Site 02 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 0.5 percentage of participants |
| BioThrax - Site 02 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 1.0 percentage of participants |
| BioThrax - Site 02 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 1.0 percentage of participants |
| BioThrax - Site 02 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 0.5 percentage of participants |
| BioThrax - Site 03 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 68.4 percentage of participants |
| BioThrax - Site 03 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 94.4 percentage of participants |
| BioThrax - Site 03 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 39.8 percentage of participants |
| BioThrax - Site 03 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 54.1 percentage of participants |
| BioThrax - Site 03 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 56.6 percentage of participants |
| BioThrax - Site 03 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 82.7 percentage of participants |
| BioThrax - Site 03 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 48.0 percentage of participants |
| BioThrax - Site 03 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 57.1 percentage of participants |
| BioThrax - Site 03 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 17.3 percentage of participants |
| BioThrax - Site 04 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 39.4 percentage of participants |
| BioThrax - Site 04 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 41.5 percentage of participants |
| BioThrax - Site 04 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 52.3 percentage of participants |
| BioThrax - Site 04 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 88.6 percentage of participants |
| BioThrax - Site 04 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 18.7 percentage of participants |
| BioThrax - Site 04 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 57.5 percentage of participants |
| BioThrax - Site 04 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 71.0 percentage of participants |
| BioThrax - Site 04 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 65.5 percentage of participants |
| BioThrax - Site 04 | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 62.7 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 36.3 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 33.7 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 72.0 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 51.8 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 37.8 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 26.4 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 45.6 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 55.4 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 10.9 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 4.7 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 2.1 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 0.5 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 2.6 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 7.3 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 3.6 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 5.2 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 9.3 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 6.7 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 0 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Warmth | 47.7 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Arm Motion Limitation | 29.0 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Redness | 43.5 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Lump | 60.6 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Tenderness | 81.3 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Itching | 37.3 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Bruise | 11.4 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Swelling | 42.5 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Pain | 58.5 percentage of participants |
Secondary
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| BioThrax | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 57.9 percentage of participants |
| BioThrax - Male | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 54.4 percentage of participants |
| BioThrax - Female | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 61.3 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 67.0 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 49.5 percentage of participants |
| BioThrax - Caucasian | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 61.5 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 37.0 percentage of participants |
| BioThrax - Site 01 | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 79.1 percentage of participants |
| BioThrax - Site 02 | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 42.4 percentage of participants |
| BioThrax - Site 03 | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 57.9 percentage of participants |
| BioThrax - Site 04 | Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 50.0 percentage of participants |
Secondary
Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
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).
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BioThrax | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 70.4 percentage of participants |
| BioThrax | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 75.0 percentage of participants |
| BioThrax | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 43.9 percentage of participants |
| BioThrax | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 99.25 percentage of participants |
| BioThrax - Male | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 19.4 percentage of participants |
| BioThrax - Male | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 45.9 percentage of participants |
| BioThrax - Male | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 percentage of participants |
| BioThrax - Male | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 24.5 percentage of participants |
| BioThrax - Female | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 9.7 percentage of participants |
| BioThrax - Female | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 4.6 percentage of participants |
| BioThrax - Female | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0.5 percentage of participants |
| BioThrax - Female | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 5.1 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 0.5 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 1.0 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 0 percentage of participants |
| BioThrax - ≤ 30 Years of Age | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0.5 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 29.6 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 25.0 percentage of participants |
| BioThrax- > 30 Years of Age | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 56.1 percentage of participants |
| BioThrax - Caucasian | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 51.5 percentage of participants |
| BioThrax - Caucasian | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 71.4 percentage of participants |
| BioThrax - Caucasian | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 68.9 percentage of participants |
| BioThrax - Caucasian | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 100 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 20.4 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 24.5 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 34.2 percentage of participants |
| BioThrax - Non-Caucasian | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 percentage of participants |
| BioThrax - Site 01 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 7.7 percentage of participants |
| BioThrax - Site 01 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 percentage of participants |
| BioThrax - Site 01 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 6.1 percentage of participants |
| BioThrax - Site 01 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 13.8 percentage of participants |
| BioThrax - Site 02 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 0.5 percentage of participants |
| BioThrax - Site 02 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 0.5 percentage of participants |
| BioThrax - Site 02 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 percentage of participants |
| BioThrax - Site 02 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 0.5 percentage of participants |
| BioThrax - Site 03 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 31.1 percentage of participants |
| BioThrax - Site 03 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 28.6 percentage of participants |
| BioThrax - Site 03 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 percentage of participants |
| BioThrax - Site 03 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 48.5 percentage of participants |
| BioThrax - Site 04 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 74.1 percentage of participants |
| BioThrax - Site 04 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 78.2 percentage of participants |
| BioThrax - Site 04 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 64.8 percentage of participants |
| BioThrax - Site 04 | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 99.5 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0.5 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 19.7 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 19.7 percentage of participants |
| BioThrax 3rd Vaccination - Mild Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 32.6 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 2.1 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 2.6 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 6.2 percentage of participants |
| BioThrax 3rd Vaccination - Moderate Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 0 percentage of participants |
| BioThrax 3rd Vaccination - Severe Reaction | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 0 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Muscle Ache | 35.2 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Headache | 25.9 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fatigue/Tiredness | 21.8 percentage of participants |
| BioThrax 3rd Vaccination - Total of Reactions | Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards | Fever | 0.5 percentage of participants |