Trial Outcomes & Findings for Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults (NCT NCT01491607)

Last Updated: 2024-04-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

200 participants

Primary outcome timeframe

Day 63 +/- 2 days

Results posted on

2024-04-09

Participant Flow

Participants were enrolled from 9 November 2011 to 9 May 2012 at four medical centers in the U.S.

All enrolled participants met the inclusion and exclusion criteria.

Participant milestones

Participant milestones
Measure	BioThrax Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
Overall Study STARTED	200
Overall Study COMPLETED	190
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	BioThrax Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BioThrax - Site 01 n=45 Participants 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.	BioThrax - Site 02 n=34 Participants 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.	BioThrax - Site 03 n=56 Participants 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.	BioThrax - Site 04 n=49 Participants Subjects from Site 04 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.	Total n=184 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	15 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	20 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	19 Participants n=7 Participants	55 Participants n=5 Participants	47 Participants n=4 Participants	164 Participants n=21 Participants
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	33 Participants n=7 Participants	56 Participants n=5 Participants	48 Participants n=4 Participants	181 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	32.0 years STANDARD_DEVIATION 11.41 • n=5 Participants	36.7 years STANDARD_DEVIATION 10.97 • n=7 Participants	32.7 years STANDARD_DEVIATION 9.89 • n=5 Participants	34.2 years STANDARD_DEVIATION 11.09 • n=4 Participants	33.7 years STANDARD_DEVIATION 10.84 • n=21 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	19 Participants n=7 Participants	29 Participants n=5 Participants	22 Participants n=4 Participants	92 Participants n=21 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants	27 Participants n=4 Participants	92 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	42 participants n=5 Participants	20 participants n=7 Participants	49 participants n=5 Participants	45 participants n=4 Participants	156 participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=5 Participants	14 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	20 participants n=21 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Region of Enrollment United States	45 participants n=5 Participants	34 participants n=7 Participants	56 participants n=5 Participants	49 participants n=4 Participants	184 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BioThrax 2nd Vaccination - Severe Reaction n=34 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 2nd Vaccination - Total of Reactions n=56 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - No Reaction n=49 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Mild Reaction The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Moderate Reaction The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Severe Reaction The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Total of Reactions The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - No Reaction n=184 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Mild Reaction n=92 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Moderate Reaction n=92 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Severe Reaction n=90 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax- > 30 Years of Age n=94 Participants Participants \> 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	BioThrax - Caucasian n=156 Participants Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Non-Caucasian n=28 Participants Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Site 01 n=45 Participants Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
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 Interval 49.5 to 82.6	69.6 percentage of participants Interval 55.9 to 81.2	57.1 percentage of participants Interval 42.2 to 71.2	—	—	—	—	71.2 percentage of participants Interval 64.1 to 77.6	68.5 percentage of participants Interval 58.0 to 77.8	73.9 percentage of participants Interval 63.7 to 82.5	76.7 percentage of participants Interval 66.6 to 84.9	66.0 percentage of participants Interval 55.5 to 75.4	73.7 percentage of participants Interval 66.1 to 80.4	57.1 percentage of participants Interval 37.2 to 75.5	91.1 percentage of participants Interval 78.8 to 97.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BioThrax 2nd Vaccination - Severe Reaction n=33 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 2nd Vaccination - Total of Reactions n=57 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - No Reaction n=50 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Mild Reaction The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Moderate Reaction The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Severe Reaction The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Total of Reactions The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - No Reaction n=183 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Mild Reaction n=90 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Moderate Reaction n=93 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Severe Reaction n=88 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax- > 30 Years of Age n=95 Participants Participants \> 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	BioThrax - Caucasian n=156 Participants Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Non-Caucasian n=27 Participants Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Site 01 n=43 Participants Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.	42.4 percentage of participants Interval 25.5 to 60.8	57.9 percentage of participants Interval 44.1 to 70.9	50.0 percentage of participants Interval 35.5 to 64.5	—	—	—	—	57.9 percentage of participants Interval 50.4 to 65.2	54.4 percentage of participants Interval 43.6 to 65.0	61.3 percentage of participants Interval 50.6 to 71.2	67.0 percentage of participants Interval 56.2 to 76.7	49.5 percentage of participants Interval 39.1 to 59.9	61.5 percentage of participants Interval 53.4 to 69.2	37.0 percentage of participants Interval 19.4 to 57.6	79.1 percentage of participants Interval 64.0 to 90.0

SECONDARY outcome

Timeframe: Days 63 to 100

Outcome measures

Outcome measures
Measure	BioThrax 2nd Vaccination - Severe Reaction n=30 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 2nd Vaccination - Total of Reactions n=52 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - No Reaction n=47 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Mild Reaction The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Moderate Reaction The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Severe Reaction The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Total of Reactions The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - No Reaction n=165 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Mild Reaction n=82 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Moderate Reaction n=83 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Severe Reaction n=77 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax- > 30 Years of Age n=88 Participants Participants \> 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	BioThrax - Caucasian n=141 Participants Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Non-Caucasian n=24 Participants Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Site 01 n=36 Participants Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).	36.7 percentage of participants Interval 19.9 to 56.1	51.9 percentage of participants Interval 37.6 to 66.0	46.8 percentage of participants Interval 32.1 to 61.9	—	—	—	—	52.7 percentage of participants Interval 44.8 to 60.5	50.0 percentage of participants Interval 38.7 to 61.3	55.4 percentage of participants Interval 44.1 to 66.3	58.4 percentage of participants Interval 46.6 to 69.6	47.7 percentage of participants Interval 37.0 to 58.6	56.0 percentage of participants Interval 47.4 to 64.4	33.3 percentage of participants Interval 15.6 to 55.3	75.0 percentage of participants Interval 57.8 to 87.9

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	BioThrax 2nd Vaccination - Severe Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 2nd Vaccination - Total of Reactions n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - No Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Mild Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Moderate Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Severe Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Total of Reactions n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - No Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Mild Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Moderate Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Severe Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax- > 30 Years of Age n=196 Participants Participants \> 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	BioThrax - Caucasian n=196 Participants Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Non-Caucasian n=196 Participants Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Site 01 n=196 Participants Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Warmth	1 participants	111 participants	101 participants	88 participants	4 participants	0 participants	92 participants	93 participants	94 participants	9 participants	0 participants	103 participants	85 participants	96 participants	14 participants
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Tenderness	2 participants	185 participants	36 participants	139 participants	18 participants	0 participants	157 participants	11 participants	134 participants	49 participants	2 participants	185 participants	11 participants	126 participants	57 participants
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Itching	1 participants	78 participants	121 participants	65 participants	7 participants	0 participants	72 participants	167 participants	27 participants	1 participants	1 participants	29 participants	118 participants	65 participants	12 participants
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Arm Motion Limitation	1 participants	94 participants	137 participants	51 participants	5 participants	0 participants	56 participants	102 participants	68 participants	22 participants	4 participants	94 participants	102 participants	66 participants	27 participants
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Redness	2 participants	112 participants	109 participants	70 participants	14 participants	0 participants	84 participants	115 participants	68 participants	12 participants	1 participants	81 participants	84 participants	80 participants	30 participants
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Lump	2 participants	134 participants	76 participants	107 participants	10 participants	0 participants	117 participants	82 participants	102 participants	11 participants	1 participants	114 participants	62 participants	109 participants	23 participants
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Bruise	1 participants	34 participants	171 participants	21 participants	1 participants	0 participants	22 participants	173 participants	23 participants	0 participants	0 participants	23 participants	162 participants	31 participants	2 participants
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Pain	2 participants	162 participants	80 participants	100 participants	13 participants	0 participants	113 participants	26 participants	123 participants	45 participants	2 participants	170 participants	34 participants	110 participants	50 participants
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Swelling	0 participants	106 participants	111 participants	73 participants	9 participants	0 participants	82 participants	111 participants	78 participants	7 participants	0 participants	85 participants	90 participants	85 participants	21 participants

SECONDARY outcome

Timeframe: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).

Outcome measures

Outcome measures
Measure	BioThrax 2nd Vaccination - Severe Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 2nd Vaccination - Total of Reactions n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - No Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Mild Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Moderate Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Severe Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Total of Reactions n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - No Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Mild Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Moderate Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Severe Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax- > 30 Years of Age n=196 Participants Participants \> 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	BioThrax - Caucasian n=196 Participants Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Non-Caucasian n=196 Participants Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Site 01 n=196 Participants Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Arm Motion Limitation	0.5 percentage of participants	48.0 percentage of participants	71.0 percentage of participants	26.4 percentage of participants	2.6 percentage of participants	0 percentage of participants	29.0 percentage of participants	52.0 percentage of participants	34.7 percentage of participants	11.2 percentage of participants	2.0 percentage of participants	48.0 percentage of participants	52.0 percentage of participants	33.7 percentage of participants	13.8 percentage of participants
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Redness	1.0 percentage of participants	57.1 percentage of participants	65.5 percentage of participants	36.3 percentage of participants	7.3 percentage of participants	0 percentage of participants	43.5 percentage of participants	58.7 percentage of participants	34.7 percentage of participants	6.1 percentage of participants	0.5 percentage of participants	41.3 percentage of participants	42.9 percentage of participants	40.8 percentage of participants	15.3 percentage of participants
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Swelling	0 percentage of participants	54.1 percentage of participants	57.5 percentage of participants	37.8 percentage of participants	4.7 percentage of participants	0 percentage of participants	42.5 percentage of participants	56.6 percentage of participants	39.8 percentage of participants	3.6 percentage of participants	0 percentage of participants	43.4 percentage of participants	45.9 percentage of participants	43.4 percentage of participants	10.7 percentage of participants
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Bruise	0.5 percentage of participants	17.3 percentage of participants	88.6 percentage of participants	10.9 percentage of participants	0.5 percentage of participants	0 percentage of participants	11.4 percentage of participants	88.3 percentage of participants	11.7 percentage of participants	0 percentage of participants	0 percentage of participants	11.7 percentage of participants	82.7 percentage of participants	15.8 percentage of participants	1.0 percentage of participants
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Warmth	0.5 percentage of participants	56.6 percentage of participants	52.3 percentage of participants	45.6 percentage of participants	2.1 percentage of participants	0 percentage of participants	47.7 percentage of participants	47.4 percentage of participants	48.0 percentage of participants	4.6 percentage of participants	0 percentage of participants	52.6 percentage of participants	43.4 percentage of participants	49.0 percentage of participants	7.1 percentage of participants
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Tenderness	1.0 percentage of participants	94.4 percentage of participants	18.7 percentage of participants	72.0 percentage of participants	9.3 percentage of participants	0 percentage of participants	81.3 percentage of participants	5.6 percentage of participants	68.4 percentage of participants	25.0 percentage of participants	1.0 percentage of participants	94.4 percentage of participants	5.6 percentage of participants	64.3 percentage of participants	29.1 percentage of participants
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Itching	0.5 percentage of participants	39.8 percentage of participants	62.7 percentage of participants	33.7 percentage of participants	3.6 percentage of participants	0 percentage of participants	37.3 percentage of participants	85.2 percentage of participants	13.8 percentage of participants	0.5 percentage of participants	0.5 percentage of participants	14.8 percentage of participants	60.2 percentage of participants	33.2 percentage of participants	6.1 percentage of participants
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Pain	1.0 percentage of participants	82.7 percentage of participants	41.5 percentage of participants	51.8 percentage of participants	6.7 percentage of participants	0 percentage of participants	58.5 percentage of participants	13.3 percentage of participants	62.8 percentage of participants	23.0 percentage of participants	1.0 percentage of participants	86.7 percentage of participants	17.3 percentage of participants	56.1 percentage of participants	25.5 percentage of participants
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Lump	1.0 percentage of participants	68.4 percentage of participants	39.4 percentage of participants	55.4 percentage of participants	5.2 percentage of participants	0 percentage of participants	60.6 percentage of participants	41.8 percentage of participants	52.0 percentage of participants	5.6 percentage of participants	0.5 percentage of participants	58.2 percentage of participants	31.6 percentage of participants	55.6 percentage of participants	11.7 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BioThrax 2nd Vaccination - Severe Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 2nd Vaccination - Total of Reactions n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - No Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Mild Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Moderate Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Severe Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Total of Reactions n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - No Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Mild Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Moderate Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Severe Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax- > 30 Years of Age n=196 Participants Participants \> 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	BioThrax - Caucasian n=196 Participants Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Non-Caucasian n=196 Participants Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Site 01 n=196 Participants Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Fatigue/Tiredness	1 participants	61 participants	151 participants	38 participants	4 participants	0 participants	42 participants	138 participants	48 participants	10 participants	0 participants	58 participants	135 participants	48 participants	12 participants
Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Muscle Ache	1 participants	95 participants	125 participants	63 participants	5 participants	0 participants	68 participants	86 participants	90 participants	19 participants	1 participants	110 participants	101 participants	67 participants	27 participants
Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Headache	1 participants	56 participants	143 participants	38 participants	12 participants	0 participants	50 participants	147 participants	38 participants	9 participants	2 participants	49 participants	140 participants	40 participants	15 participants
Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Fever	0 participants	0 participants	192 participants	1 participants	0 participants	0 participants	1 participants	195 participants	0 participants	1 participants	0 participants	1 participants	196 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).

Outcome measures

Outcome measures
Measure	BioThrax 2nd Vaccination - Severe Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 2nd Vaccination - Total of Reactions n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - No Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Mild Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Moderate Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Severe Reaction n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 3rd Vaccination - Total of Reactions n=193 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - No Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Mild Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Moderate Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax 1st Vaccination - Severe Reaction n=196 Participants The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period	BioThrax- > 30 Years of Age n=196 Participants Participants \> 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.	BioThrax - Caucasian n=196 Participants Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Non-Caucasian n=196 Participants Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..	BioThrax - Site 01 n=196 Participants Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Fatigue/Tiredness	0.5 percentage of participants	31.1 percentage of participants	78.2 percentage of participants	19.7 percentage of participants	2.1 percentage of participants	0 percentage of participants	21.8 percentage of participants	70.4 percentage of participants	24.5 percentage of participants	5.1 percentage of participants	0 percentage of participants	29.6 percentage of participants	68.9 percentage of participants	24.5 percentage of participants	6.1 percentage of participants
Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Muscle Ache	0.5 percentage of participants	48.5 percentage of participants	64.8 percentage of participants	32.6 percentage of participants	2.6 percentage of participants	0 percentage of participants	35.2 percentage of participants	43.9 percentage of participants	45.9 percentage of participants	9.7 percentage of participants	0.5 percentage of participants	56.1 percentage of participants	51.5 percentage of participants	34.2 percentage of participants	13.8 percentage of participants
Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Headache	0.5 percentage of participants	28.6 percentage of participants	74.1 percentage of participants	19.7 percentage of participants	6.2 percentage of participants	0 percentage of participants	25.9 percentage of participants	75.0 percentage of participants	19.4 percentage of participants	4.6 percentage of participants	1.0 percentage of participants	25.0 percentage of participants	71.4 percentage of participants	20.4 percentage of participants	7.7 percentage of participants
Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards Fever	0 percentage of participants	0 percentage of participants	99.5 percentage of participants	0.5 percentage of participants	0 percentage of participants	0 percentage of participants	0.5 percentage of participants	99.25 percentage of participants	0 percentage of participants	0.5 percentage of participants	0 percentage of participants	0.5 percentage of participants	100 percentage of participants	0 percentage of participants	0 percentage of participants

Adverse Events

ITT Population

Serious events: 2 serious events

Other events: 109 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ITT Population n=200 participants at risk Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
Metabolism and nutrition disorders Obesity	0.50% 1/200 • Number of events 1 • Adverse event data were collected from the time of screening up to 100 days post dose.
Nervous system disorders Aura	0.50% 1/200 • Number of events 1 • Adverse event data were collected from the time of screening up to 100 days post dose.

Other adverse events

Other adverse events
Measure	ITT Population n=200 participants at risk Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
Infections and infestations Upper respiratory tract infection	18.5% 37/200 • Number of events 44 • Adverse event data were collected from the time of screening up to 100 days post dose.
Nervous system disorders Headache	12.5% 25/200 • Number of events 31 • Adverse event data were collected from the time of screening up to 100 days post dose.
General disorders Fatigue	6.5% 13/200 • Number of events 17 • Adverse event data were collected from the time of screening up to 100 days post dose.
Musculoskeletal and connective tissue disorders Myalgia	6.0% 12/200 • Number of events 14 • Adverse event data were collected from the time of screening up to 100 days post dose.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.0% 12/200 • Number of events 12 • Adverse event data were collected from the time of screening up to 100 days post dose.
Infections and infestations Nasopharyngitis	5.0% 10/200 • Number of events 11 • Adverse event data were collected from the time of screening up to 100 days post dose.

Additional Information

Dr. Robert Hopkins

Emergent BioSolutions

Phone: (301) 944-0136

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER