A Phase 3 interventional study of BioThrax in Anthrax, sponsored by Emergent BioSolutions. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Emergent BioSolutions · Phase 3, Interventional, and Treatment
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.
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.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: BioThrax
BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.
Also known as: Anthrax Vaccine Adsorbed (AVA)
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
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
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
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).
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).
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).
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).
Participants were enrolled from 9 November 2011 to 9 May 2012 at four medical centers in the U.S.
| Milestone | BioThrax |
|---|---|
| Started | 200 |
| Completed | 190 |
| Not completed | 10 |
| Withdrew: Lost to follow-up | 7 |
| Withdrew: Withdrawal by subject | 3 |
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.
| percentage of participants | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 (64.1 to 77.6) | 68.5 (58.0 to 77.8) | 73.9 (63.7 to 82.5) | 76.7 (66.6 to 84.9) | 66.0 (55.5 to 75.4) | 73.7 (66.1 to 80.4) | 57.1 (37.2 to 75.5) | 91.1 (78.8 to 97.5) | 67.6 (49.5 to 82.6) | 69.6 (55.9 to 81.2) | 57.1 (42.2 to 71.2) |
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.
| percentage of participants | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70. | 57.9 (50.4 to 65.2) | 54.4 (43.6 to 65.0) | 61.3 (50.6 to 71.2) | 67.0 (56.2 to 76.7) | 49.5 (39.1 to 59.9) | 61.5 (53.4 to 69.2) | 37.0 (19.4 to 57.6) | 79.1 (64.0 to 90.0) | 42.4 (25.5 to 60.8) | 57.9 (44.1 to 70.9) | 50.0 (35.5 to 64.5) |
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.
| percentage of participants | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive). | 52.7 (44.8 to 60.5) | 50.0 (38.7 to 61.3) | 55.4 (44.1 to 66.3) | 58.4 (46.6 to 69.6) | 47.7 (37.0 to 58.6) | 56.0 (47.4 to 64.4) | 33.3 (15.6 to 55.3) | 75.0 (57.8 to 87.9) | 36.7 (19.9 to 56.1) | 51.9 (37.6 to 66.0) | 46.8 (32.1 to 61.9) |
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.
| participants | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Warmth | 93 | 94 | 9 | 0 | 103 | 85 | 96 | 14 | 1 | 111 | 101 | 88 | 4 | 0 | 92 |
| Tenderness | 11 | 134 | 49 | 2 | 185 | 11 | 126 | 57 | 2 | 185 | 36 | 139 | 18 | 0 | 157 |
| Itching | 167 | 27 | 1 | 1 | 29 | 118 | 65 | 12 | 1 | 78 | 121 | 65 | 7 | 0 | 72 |
| Pain | 26 | 123 | 45 | 2 | 170 | 34 | 110 | 50 | 2 | 162 | 80 | 100 | 13 | 0 | 113 |
| Arm Motion Limitation | 102 | 68 | 22 | 4 | 94 | 102 | 66 | 27 | 1 | 94 | 137 | 51 | 5 | 0 | 56 |
| Redness | 115 | 68 | 12 | 1 | 81 | 84 | 80 | 30 | 2 | 112 | 109 | 70 | 14 | 0 | 84 |
| Swelling | 111 | 78 | 7 | 0 | 85 | 90 | 85 | 21 | 0 | 106 | 111 | 73 | 9 | 0 | 82 |
| Lump | 82 | 102 | 11 | 1 | 114 | 62 | 109 | 23 | 2 | 134 | 76 | 107 | 10 | 0 | 117 |
| Bruise | 173 | 23 | 0 | 0 | 23 | 162 | 31 | 2 | 1 | 34 | 171 | 21 | 1 | 0 | 22 |
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 participants | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Warmth | 47.4 | 48.0 | 4.6 | 0 | 52.6 | 43.4 | 49.0 | 7.1 | 0.5 | 56.6 | 52.3 | 45.6 | 2.1 | 0 | 47.7 |
| Tenderness | 5.6 | 68.4 | 25.0 | 1.0 | 94.4 | 5.6 | 64.3 | 29.1 | 1.0 | 94.4 | 18.7 | 72.0 | 9.3 | 0 | 81.3 |
| Itching | 85.2 | 13.8 | 0.5 | 0.5 | 14.8 | 60.2 | 33.2 | 6.1 | 0.5 | 39.8 | 62.7 | 33.7 | 3.6 | 0 | 37.3 |
| Pain | 13.3 | 62.8 | 23.0 | 1.0 | 86.7 | 17.3 | 56.1 | 25.5 | 1.0 | 82.7 | 41.5 | 51.8 | 6.7 | 0 | 58.5 |
| Arm Motion Limitation | 52.0 | 34.7 | 11.2 | 2.0 | 48.0 | 52.0 | 33.7 | 13.8 | 0.5 | 48.0 | 71.0 | 26.4 | 2.6 | 0 | 29.0 |
| Redness | 58.7 | 34.7 | 6.1 | 0.5 | 41.3 | 42.9 | 40.8 | 15.3 | 1.0 | 57.1 | 65.5 | 36.3 | 7.3 | 0 | 43.5 |
| Swelling | 56.6 | 39.8 | 3.6 | 0 | 43.4 | 45.9 | 43.4 | 10.7 | 0 | 54.1 | 57.5 | 37.8 | 4.7 | 0 | 42.5 |
| Lump | 41.8 | 52.0 | 5.6 | 0.5 | 58.2 | 31.6 | 55.6 | 11.7 | 1.0 | 68.4 | 39.4 | 55.4 | 5.2 | 0 | 60.6 |
| Bruise | 88.3 | 11.7 | 0 | 0 | 11.7 | 82.7 | 15.8 | 1.0 | 0.5 | 17.3 | 88.6 | 10.9 | 0.5 | 0 | 11.4 |
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.
| participants | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fatigue/Tiredness | 138 | 48 | 10 | 0 | 58 | 135 | 48 | 12 | 1 | 61 | 151 | 38 | 4 | 0 | 42 |
| Muscle Ache | 86 | 90 | 19 | 1 | 110 | 101 | 67 | 27 | 1 | 95 | 125 | 63 | 5 | 0 | 68 |
| Headache | 147 | 38 | 9 | 2 | 49 | 140 | 40 | 15 | 1 | 56 | 143 | 38 | 12 | 0 | 50 |
| Fever | 195 | 0 | 1 | 0 | 1 | 196 | 0 | 0 | 0 | 0 | 192 | 1 | 0 | 0 | 1 |
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 participants | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fatigue/Tiredness | 70.4 | 24.5 | 5.1 | 0 | 29.6 | 68.9 | 24.5 | 6.1 | 0.5 | 31.1 | 78.2 | 19.7 | 2.1 | 0 | 21.8 |
| Muscle Ache | 43.9 | 45.9 | 9.7 | 0.5 | 56.1 | 51.5 | 34.2 | 13.8 | 0.5 | 48.5 | 64.8 | 32.6 | 2.6 | 0 | 35.2 |
| Headache | 75.0 | 19.4 | 4.6 | 1.0 | 25.0 | 71.4 | 20.4 | 7.7 | 0.5 | 28.6 | 74.1 | 19.7 | 6.2 | 0 | 25.9 |
| Fever | 99.25 | 0 | 0.5 | 0 | 0.5 | 100 | 0 | 0 | 0 | 0 | 99.5 | 0.5 | 0 | 0 | 0.5 |
Collected over Adverse event data were collected from the time of screening up to 100 days post dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ITT Population | — | 2/200 (1%) | 109/200 (54.5%) |
| Event | ITT Population |
|---|---|
| ObesityMetabolism and nutrition disorders | 1/200 |
| AuraNervous system disorders | 1/200 |
| Event | ITT Population |
|---|---|
| Upper respiratory tract infectionInfections and infestations | 37/200 |
| HeadacheNervous system disorders | 25/200 |
| FatigueGeneral disorders | 13/200 |
| MyalgiaMusculoskeletal and connective tissue disorders | 12/200 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 12/200 |
| NasopharyngitisInfections and infestations | 10/200 |
Participants 18 to 65 years of age 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.
| Age, Categorical(Participants) | BioThrax - Site 01 | BioThrax - Site 02 | BioThrax - Site 03 | BioThrax - Site 04 | Total |
|---|---|---|---|---|---|
| <=18 years | 1 | 1 | 0 | 1 | 3 |
| Between 18 and 65 years | 44 | 33 | 56 | 48 | 181 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | BioThrax - Site 01 | BioThrax - Site 02 | BioThrax - Site 03 | BioThrax - Site 04 | Total |
|---|---|---|---|---|---|
| Mean | 32.0 ± 11.41 | 36.7 ± 10.97 | 32.7 ± 9.89 | 34.2 ± 11.09 | 33.7 ± 10.84 |
| Sex: Female, Male(Participants) | BioThrax - Site 01 | BioThrax - Site 02 | BioThrax - Site 03 | BioThrax - Site 04 | Total |
|---|---|---|---|---|---|
| Female | 22 | 19 | 29 | 22 | 92 |
| Male | 23 | 15 | 27 | 27 | 92 |
| Ethnicity (NIH/OMB)(Participants) | BioThrax - Site 01 | BioThrax - Site 02 | BioThrax - Site 03 | BioThrax - Site 04 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 15 | 1 | 2 | 20 |
| Not Hispanic or Latino | 43 | 19 | 55 | 47 | 164 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | BioThrax - Site 01 | BioThrax - Site 02 | BioThrax - Site 03 | BioThrax - Site 04 | Total |
|---|---|---|---|---|---|
| White | 42 | 20 | 49 | 45 | 156 |
| Black or African American | 0 | 14 | 3 | 3 | 20 |
| Asian | 2 | 0 | 2 | 1 | 5 |
| American Indian or Alaska Native | 1 | 0 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | BioThrax - Site 01 | BioThrax - Site 02 | BioThrax - Site 03 | BioThrax - Site 04 | Total |
|---|---|---|---|---|---|
| United States | 45 | 34 | 56 | 49 | 184 |
The record gives a start of Nov 2011, a primary completion of May 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2013, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Biothrax